Atlas FDA

Liberant Thrombectomy System

FDA 510(k) clearance K250787 · decided 2025-06-11

Clearance details

K-number
K250787
Device name
Liberant Thrombectomy System
Applicant
Medtronic, Ireland
Decision
Substantially Equivalent
Date received
2025-03-14
Decision date
2025-06-11
Days to decision
89 days
Clearance type
Traditional
Product code
QEW
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Galway, IE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Integrity Coronary Stent Systems (P030009/S101)Medtronic, Ireland2022-07-15
Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System (P030009/S107)Medtronic, Ireland2022-04-19
Integrity Coronary Stent System (P030009/S104)Medtronic, Ireland2022-01-27
Integrity Coronary Stent System RX and OTW (P030009/S105)Medtronic, Ireland2021-12-14
Integrity Coronary Stent System Rx and OTW (P030009/S106)Medtronic, Ireland2021-11-16
Integrity Coronary Stent System Rx and OTW (P030009/S103)Medtronic, Ireland2021-05-21
Integrity Coronary Stent System (hereafter called Integrity) (P030009/S102)Medtronic, Ireland2021-05-11
Integrity Coronary Stent System (P030009/S100)Medtronic, Ireland2021-03-12