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FDA 510(k)

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

K-Number: K251185 · 2025-10-22

ApplicantIntervene
Decision Date2025-10-22
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is a medical device manufactured by Intervene. It received FDA 510(k) clearance on 2025-10-22 under approval number K251185. 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 Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Intervene. The 510(k) number is K251185.

When was Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) approved by the FDA?

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) received FDA 510(k) clearance on 2025-10-22, under approval number K251185.

What company makes Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is manufactured by Intervene.

What is the FDA product code for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

The FDA product code for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is QEW.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06394739 RevCore for In Stent Thrombosis RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING

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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