Atlas FDA

NRY

110 FDA 510(k) clearances · Product code

122 daysmedian time to decision
257 days90th percentile
110clearances measured

FDA profile

Official device name
Catheter, Thrombus Retriever
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Medical specialty
Cardiovascular
FDA definition
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Adverse events (MAUDE)
2021: 688 · 2022: 549 · 2023: 711 · 2024: 641 · 2025: 572 · 2026: 276
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Socrates Aspiration System (Socrates 70 Aspiration Catheter) (K260002)Scientia Vascular, Inc.2026-07-16
Penumbra System (Thunderbolt Aspiration Tubing) (K250690)Penumbra, Inc.2026-06-10
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (K252707)Suzhou Zenith Vascular SciTech Limited2026-05-20
Lynx Aspiration Catheter System (K254276)Q’Apel Medical, Inc.2026-05-07
Millipede System (K253590)Perfuze, Ltd.2026-03-16
Tigertriever 25 Revascularization Device (K253062)Rapid Medical Ltd.2026-03-12
Esperance pHLO Aspiration System (K251357)Phenox, Ltd.2026-01-15
NeVasc Aspiration System (K251006)Vesalio, Inc.2025-11-10
Zoom System (Zoom 4S Catheter) (K252046)Imperative Care, Inc.2025-10-30
Tigertriever 17 Ultra Revascularization Device (K251603)Rapid Medical Ltd.2025-10-06
EMBOTRAP III Revascularization Device (K251789)Neuravi Limited2025-09-25
Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392)Perfuze, Ltd.2025-08-29
CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (K251828)Cerenovus, Inc.2025-08-22
Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948)Balt USA, LLC2025-06-03
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (K243047)Imperative Care, Inc.2025-05-28
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601)Route 92 Medical, Inc.2025-05-19
APRO 45 Catheter and Alembic Aspiration Tubing (K251015)Alembic, LLC2025-04-30
APRO 55 Swift Catheter and Alembic Aspiration Tubing (K250958)Alembic, LLC2025-04-28
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012)Perfuze, Ltd.2025-02-26
APRO 70 Swift Catheter and Alembic Aspiration Tubing (K243287)Alembic, LLC2025-02-24
Penumbra System (Reperfusion Catheter RED 72) (K242104)Penumbra, Inc.2025-02-13
Zoom System (K242672)Imperative Care, Inc.2025-01-14
Riptide Aspiration System (K243080)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-10-29
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221)Cerenovus, Inc.2024-10-16
Esperance 3+ Aspiration Catheter System (K240917)Wallaby Medical2024-10-01
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K242504)Perfuze, Ltd.2024-09-20
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (K234083)Balt USA, LLC2024-07-02
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set (K233329)Route 92 Medical, Inc.2024-04-23
APRO 55 Catheter and Alembic Aspiration Tubing (K232971)Alembic, LLC2024-02-29
Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set (K233988)Cerenovus, Inc.2024-01-17
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K232524)Perfuze, Ltd.2023-10-18
Socrates Aspiration System (K223913)Scientia Vascular, Inc.2023-09-20
072 Aspiration System (K222786)Q'Apel Medical, Inc.2023-08-25
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device (K230429)Rapid Medical Ltd.2023-04-17
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (K223530)Route 92 Medical, Inc.2023-04-11
APRO 70 Catheter and Alembic Aspiration Tubing (K230695)Alembic, LLC2023-04-10
CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934)Cerenovus, Inc.2023-03-09
APRO 70 Catheter and Alembic Aspiration Tubing (K223545)Alembic, LLC2023-02-17
Penumbra System (Reperfusion Catheter RED 43) (K222808)Penumbra, Inc.2022-12-20
Tigertriever 13 Revascularization Device (K220808)Rapid Medical Ltd.2022-07-25
ERIC Retrieval Device (K211120)MicroVention, Inc.2022-03-31
Esperance Aspiration Catheter System (K211697)Wallaby Medical2021-11-16
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device (K212908)Neuravi, Ltd.2021-10-13
Penumbra System (Reperfusion Catheter RED 72) (K211654)Penumbra, Inc.2021-08-16
EMBOTRAP III Revascularization Device (K211338)Neuravi, Ltd.2021-07-30
Penumbra System (RED 68 Reperfusion Catheter) (K211411)Penumbra, Inc.2021-07-01
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing (K211476)Imperative Care, Inc.2021-06-08
Penumbra System (Reperfusion Catheter RED 62) (K203440)Penumbra, Inc.2021-05-20
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K210996)Imperative Care, Inc.2021-04-23
Tigertriever and Tigertriever 17 Revascularization Devce (K203592)Rapid Medical Ltd.2021-03-23
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K202182)Imperative Care, Inc.2020-09-02
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) (K202251)Penumbra, Inc.2020-08-31
Riptide Aspiration System (K201689)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-07-21
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380)Codman & Shurtleff, Inc.2020-07-20
EMBOTRAP III Revascularization Device (K193063)Neuravi, Ltd.2020-07-14
Penumbra System Penumbra JET 7X (K191946)Penumbra, Inc.2020-02-27
046 Zenith Flex (K190338)Inneuroco, Inc.2019-08-02
AXS Vecta Aspiration System (K191768)Stryker Neurovascular2019-07-30
Penumbra System Reperfusion Catheter JET 7 (K190010)Penumbra, Inc.2019-06-16
Penumbra System 3D Revascularization Device (K190464)Penumbra, Inc.2019-04-26
AXS Vecta Aspiration System (K190212)Stryker Neurovascular2019-04-24
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter (K183043)Imperative Care, Inc.2019-04-17
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) (K183464)Stryker2019-03-13
Riptide Aspiration System (Riptide Large Bore Aspiration System) (K183185)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2018-12-18
Riptide Aspiration System (React 71 Catheter) (K182101)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2018-11-14
074 Zenith Flex System (K181354)Inneuroco, Inc.2018-10-25
Penumbra System (Modified 110 Aspiration Tubing) (K182522)Penumbra, Inc.2018-10-12
Penumbra System Reperfusion Catheter JET 7 (K173761)Penumbra, Inc.2018-08-17
Riptide Aspiration System React 68 Catheter (K180705)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2018-07-04
Penumbra System (K180008)Penumbra, Inc.2018-06-20
SOFIA Plus Aspiration Catheter (K173200)MicroVention, Inc.2018-06-11
EmboTrap ll Revascularization Device (K173452)Neuravi, Ltd.2018-05-09
Zenith Flex System (K172167)Inneuroco, Inc.2018-04-19
AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm (K173841)Stryker2018-03-18
Riptide Aspiration System (K172448)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2017-12-21
Penumbra 3D Revascularization Device (K162901)Penumbra, Inc.2017-04-20
Solitaire Platinum Revascularization Device, 6x40 mm (K160641)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2017-03-08
Solitaire Platinum Revascularization Device (K161879)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2016-09-21
Penumbra System ACE 68 Reperfusion Catheter (K161640)Penumbra, Inc.2016-07-12
Penumbra System ACE 68 Reperfusion Catheter (K161064)Penumbra, Inc.2016-06-12
Penumbra System, Penumbra Pump MAX (K160449)Penumbra, Inc.2016-05-25
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K152541)Penumbra, Inc.2016-01-13
Solitaire Platinum Revascularization Device (K153071)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2015-12-23
Penumbra System 110 Aspiration Tubing (K151623)Penumbra, Inc.2015-08-06
Trevo XP ProVue Retriever (4x30mm) (K150616)Concentric Medical, Inc.2015-06-12
Penumbra System ACE (K142458)Penumbra, Inc.2015-05-22
Trevo XP ProVue Retriever (6X25mm) (K143077)Concentric Medical, Inc.2015-04-06
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE (K141516)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2015-02-05
SOLITAIRE 2 REVASCULARIZATION DEVICE (K141491)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-10-22
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX (K133317)Penumbra, Inc.2014-05-13
MODIFIED TREVO PROVUE RETRIEVER (K133464)Concentric Medical, Inc.2014-01-17
MODIFIED TREVO PROVUE RETRIEVER (K132641)Concentric Medical, Inc.2014-01-13
SOLITAIRE 2 REVASCULARIZATION DEVICE (K123378)Micro Therapeutics Dba Ev3 Neurovascular2012-11-30
MODIFIED TREVO RETRIEVER (K122478)Concentric Medical, Inc.2012-10-31
TREVO RETRIEVER (K120961)Concentric Medical, Inc.2012-08-03
SOLITAIRE FR REVASCULARIZATION DEVICE (K113455)Micro Therapeutics Dba Ev3 Neurovascular2012-03-02
PENUMBRA SYSTEM MAX (K113163)Penumbra, Inc.2011-11-23
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 (K093610)Concentric Medical, Inc.2011-02-17
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 (K100769)Penumbra, Inc.2010-05-21
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 (K090752)Penumbra, Inc.2009-09-21
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