FDA 510(k)

Stratus Infusion Catheter

K-Number: K222185 · 2023-04-13

Decision Date2023-04-13

Product CodeNPG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Stratus Infusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Intervene, Inc.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222185. The device is classified under product code NPG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stratus Infusion Catheter?

Stratus Infusion Catheter is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Intervene, Inc.. The 510(k) number is K222185.

When did Stratus Infusion Catheter receive FDA 510(k) clearance?

Stratus Infusion Catheter received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222185.

Who is the listed applicant for Stratus Infusion Catheter?

The FDA 510(k) record lists Intervene, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stratus Infusion Catheter?

The FDA product code for Stratus Infusion Catheter is NPG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07095660RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)RECRUITING NCT07529756The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis RegistryNOT_YET_RECRUITING

Other records listing Intervene, Inc. as applicant

K251185Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

Official Source

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