510(k) K211013

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 by Inari Medical, Inc. — Product Code QEW

K211013 is an FDA 510(k) premarket notification submitted by Inari Medical, Inc. for the device "FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24". The FDA issued a decision of Substantially Equivalent on Apr 30, 2021. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Inari Medical, Inc. has 57 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 30, 2021
Date Received
Apr 5, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peripheral Mechanical Thrombectomy With Aspiration
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type
510(k)

To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.