Atlas FDA

JETi™Hydrodynamic Thrombectomy System

FDA 510(k) clearance K232458 · decided 2023-12-19

Clearance details

K-number
K232458
Device name
JETi™Hydrodynamic Thrombectomy System
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2023-08-15
Decision date
2023-12-19
Days to decision
126 days
Clearance type
Traditional
Product code
QEZ
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Clara, CA, US
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
Powered Aventus Thrombectomy System™ (K261105)Inquis Medical2026-07-27
Aventus Thrombectomy System (K262030)Inquis Medical2026-07-15
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FLOWRUNNER Aspiration System (K254208)Expanse Medical, Inc.2026-03-20
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AlphaVac Multipurpose Mechanical Aspiration System F1885 (K252509)AngioDynamics, Inc.2025-11-24
Vesalio Peripheral System (K251312)Vesalio, Inc.2025-10-24
FLOWRUNNER Aspiration System (K251488)Expanse Medical, Inc.2025-07-14
JETi Hydrodynamic Thrombectomy System (K243549)ABBOTT MEDICAL2025-04-04
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) (K250013)Control Medical Technology, Inc. / Dba Ventiv Scientific2025-03-24
AlphaVac MMA F1885 System (H787253020) (K240397)AngioDynamics, Inc.2024-04-01
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388)AngioDynamics, Inc.2022-04-04

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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HeartMate II™ Left Ventricular Assist System (P060040/S122)ABBOTT MEDICAL2025-12-17
HeartMate 3™ Left Ventricular Assist System (P160054/S116)ABBOTT MEDICAL2025-12-17
Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09