Atlas FDA

QEW

142 FDA 510(k) clearances · Product code

78 daysmedian time to decision
217 days90th percentile
142clearances measured

FDA profile

Official device name
Peripheral Mechanical Thrombectomy With Aspiration
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Medical specialty
Cardiovascular
FDA definition
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Adverse events (MAUDE)
2021: 322 · 2022: 125 · 2023: 165 · 2024: 162 · 2025: 208 · 2026: 106
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Vertex™ Thrombectomy System (K261523)Jupiter Endovascular2026-08-04
INDIGO® Aspiration System – INDIGO Link (K260599)Penumbra, Inc.2026-04-24
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (K260028)Argon Medical Devices, Inc.2026-02-05
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (K251949)Penumbra, Inc.2026-02-05
RoVo Mechanical Thrombectomy System (K253730)Verge Medical, Inc.2026-01-21
Sangria™ Thrombectomy System (K251207)Avantec Vascular Corporation2026-01-07
Helo Thrombectomy System (K252956)Endovascular Engineering, Inc.2025-12-18
Akura Thrombectomy System (K251070)Akura Medical2025-11-25
Protrieve Sheath (K253323)Inari Medical2025-10-29
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) (K251185)Intervene2025-10-22
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (K252612)Penumbra, Inc.2025-10-16
Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057)Imperative Care, Inc.2025-08-28
Aventus Thrombectomy System (K251189)Inquis Medical2025-06-13
Excipio LV Prime Thrombectomy Device (K251485)Contego Medical, Inc.2025-06-13
Liberant Thrombectomy System (K250787)Medtronic, Ireland2025-06-11
Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System (K250775)Imperative Care, Inc.2025-05-14
InThrill™ Thrombectomy System (K250421)Inari Medical, Inc.2025-05-12
Aventus Thrombectomy System (IM-2100) (K250668)Inquis Medical2025-03-25
FlowTriever2 Catheter (K250088)Inari Medical, Inc.2025-03-13
Aventus Thrombectomy System (K250202)Inquis Medical2025-02-26
Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (K241894)Inari Medical, Inc.2024-10-15
ClotTriever XL Catheter (41-102) (K242557)Inari Medical, Inc.2024-09-27
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K242075)Penumbra, Inc.2024-09-25
Pounce XL Thrombectomy System (PTS-1011-7F135) (K241362)Surmodics,Inc.2024-09-11
Indigo® Aspiration System – Aspiration Catheter 6X (K242319)Penumbra, Inc.2024-09-03
ICHOR 7F Embolectomy System (ICH-7F) (K233917)Ichor2024-07-18
Indigo® Lightning Flash Aspiration System – Select +™ Catheter (K241399)Penumbra, Inc.2024-06-10
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) (K241207)Devoro Medical, Inc.2024-05-29
ICE Aspiration System (K234073)Expanse Medical, Inc.2024-04-19
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (K233909)Argon Medical Devices, Inc.2024-03-28
Aventus Thrombectomy System (IM-2001/IM-0002) (K240117)Inquis Medical2024-03-15
VenaCore Thrombectomy Catheter (46-101) (K234034)Inari Medical, Inc.2024-02-09
Indigo® Aspiration System - Lightning® Flash (K240030)Penumbra, Inc.2024-02-02
Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister (K232679)Argon Medical Devices, Inc.2024-01-19
ClotTriever Sheath (K233815)Inari Medical, Inc.2023-12-18
Aventus Thrombectomy System (K232730)Inquis Medical2023-11-01
ICHOR 14F Embolectomy System (K230743)Ichor2023-09-05
Triever20 Curve (21-201) (K231848)Inari Medical, Inc.2023-07-21
Pounce™ Thrombectomy System (K231022)Surmodics,Inc.2023-06-12
Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) (K223929)Innova Vascular, Inc.2023-06-01
Excipio SV Aspiration Catheter and Tubing (K230030)Contego Medical, Inc.2023-05-30
Artix BG (K230912)Inari Medical2023-05-02
ClotTriever XL Catheter (K223210)Inari Medical, Inc.2023-04-27
ClotTriever BOLD Catheter (K230494)Inari Medical, Inc.2023-04-18
ROVO Mechanical Thrombectomy Device (K220780)2mg, Inc.2023-03-31
Aspirex™ Thrombectomy System (K230356)C.R. Bard, Inc.2023-03-31
Triever16 Curve (K223419)Inari Medical2023-03-23
InThrill Thrombectomy System (K223613)Inari Medical, Inc.2023-03-17
RevCore™ Thrombectomy Catheter. (K223609)Inari Medical, Inc.2023-03-14
Protrieve Sheath (K230331)Inari Medical, Inc.2023-03-07
Artix AX (K223436)Inari Medical2023-03-02
Symphony Thrombectomy System (K223216)Truvic Medical, Inc.2023-02-23
Excipio LV Thrombectomy Device (K223897)Contego Medical, Inc.2023-02-17
Cobra Catheter System (K223891)Endovascular Engineering2023-02-15
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K223186)Penumbra, Inc.2023-02-13
ClotTriever Thrombectomy System (K221531)Inari Medical, Inc.2023-02-06
Artix BG (K223000)Inari Medical2023-01-11
Indigo Aspiration System - Lightning Flash (K222358)Penumbra, Inc.2022-12-20
WOLF Thrombectomy™ SmartClaw Catheter (K221391)Devoro Medical, Inc.2022-11-10
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (K220683)Penumbra, Inc.2022-10-04
Mini-ClotTriever Thrombectomy System (K220887)Inari Medical2022-08-04
Protrieve Sheath (K220415)Inari Medical, Inc.2022-07-12
Excipio SV Thrombectomy Device (K221204)Contego Medical, Inc.2022-06-23
Aspirex Thrombectomy System (K220270)C.R. Bard, Inc.2022-06-21
Triever24, Triever20 (K213402)Inari Medical2022-05-23
Prodigy Thrombectomy System (K214114)Truvic Medical, Inc.2022-04-06
Artix Thrombectomy Device (K220600)Inari Medical2022-03-25
Pounce Thrombectomy System (K220501)Surmodics,Inc.2022-03-23
Cleaner Plus Thrombectomy System (K211798)Argon Medical Devices, Inc.2022-02-24
WOLF Thrombectomy System, 14F (K210911)Devoro Medical, Inc.2021-10-19
ClotTriever Thrombectomy System (K212632)Inari Medical, Inc.2021-10-18
WOLF Thrombectomy System, 6F (K210530)Devoro Medical, Inc.2021-08-27
Pounce Thrombectomy System (K211492)Surmodics,Inc.2021-07-30
ClotTriever Thrombectomy System (K210689)Inari Medical, Inc.2021-05-12
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 (K211013)Inari Medical, Inc.2021-04-30
Indigo Aspiration System - Lightning Aspiration Tubing (K210323)Penumbra, Inc.2021-02-26
Triever Catheters (K210195)Inari Medical2021-02-24
ClotTriever Thrombectomy System (K210190)Irani Medical, Inc.2021-02-23
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 (K210083)Penumbra, Inc.2021-02-09
NeVa PV Thrombectomy Device (K201085)Vesalio2021-01-15
ReVene Thrombectomy Catheter (K201705)Vetex Medical, Ltd.2020-12-22
CAPERE Thrombectomy System (K203476)Vascular Medcure, Inc.2020-12-22
FlowTriever Retrieval/Aspiration System (K202345)Inari Medical2020-12-18
Triever20 Curve Catheter (K203333)Inari Medical, Inc.2020-12-10
FlowTriever Retrieval/Aspiration System (K201541)Inari Medical2020-12-04
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (K202821)Penumbra, Inc.2020-11-18
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device (K202218)Boston Scientific Corporation2020-10-02
Pounce Thrombus Retrieval System (K192814)Surmodics,Inc.2020-09-21
ClotTriever Thrombectomy System (K193462)Inari Medical2020-09-09
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 (K193595)Penumbra, Inc.2020-08-19
CAPERE Thrombectomy System (K201216)Vascular Medcure, Inc.2020-07-08
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 (K192981)Penumbra, Inc.2020-05-28
WOLF Thrombectomy V System (K200101)Devoro Medical, Inc.2020-04-27
Indigo Aspiration System Lightning Aspiration Tubing (K200771)Penumbra, Inc.2020-04-22
Indigo Aspiration System – Lightning Aspiration Tubing (K193244)Penumbra, Inc.2020-03-13
Capere Thrombectomy System (K200314)Vascular Medcure, Inc.2020-03-04
Indigo Aspiration System (K192833)Penumbra, Inc.2019-12-20
CAPERE Thrombectomy System (K192935)Vascular Medcure, Inc.2019-11-15
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath (K192332)Inari Medical2019-09-20
FlowTriever Retrieval/Aspiration System (K191710)Inari Medical2019-09-05
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