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FDA 510(k)

Pounce™ Thrombectomy System

K-Number: K231022 · 2023-06-12

ApplicantSurmodics,Inc.
Decision Date2023-06-12
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pounce™ Thrombectomy System is a medical device manufactured by Surmodics,Inc.. It received FDA 510(k) clearance on 2023-06-12 under approval number K231022. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pounce™ Thrombectomy System?

Pounce™ Thrombectomy System is a medical device that received FDA 510(k) clearance on 2023-06-12. It is manufactured by Surmodics,Inc.. The 510(k) number is K231022.

When was Pounce™ Thrombectomy System approved by the FDA?

Pounce™ Thrombectomy System received FDA 510(k) clearance on 2023-06-12, under approval number K231022.

What company makes Pounce™ Thrombectomy System?

Pounce™ Thrombectomy System is manufactured by Surmodics,Inc..

What is the FDA product code for Pounce™ Thrombectomy System?

The FDA product code for Pounce™ Thrombectomy System is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING

Other Devices by Surmodics,Inc.

K173560Microcatheter K190644Guide Sheath K192814Pounce Thrombus Retrieval System K211492Pounce Thrombectomy System K221886Sublime Microcatheter K220501Pounce Thrombectomy System

View all 12 devices →

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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