FDA 510(k)

Indy OTW Vascular Retriever

K-Number: K160593 · 2016-09-02

Decision Date2016-09-02

Product CodeMMX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Indy OTW Vascular Retriever is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-09-02 under approval number K160593. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Indy OTW Vascular Retriever?

Indy OTW Vascular Retriever is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Cook Incorporated. The 510(k) number is K160593.

When was Indy OTW Vascular Retriever approved by the FDA?

Indy OTW Vascular Retriever received FDA 510(k) clearance on 2016-09-02, under approval number K160593.

What company makes Indy OTW Vascular Retriever?

Indy OTW Vascular Retriever is manufactured by Cook Incorporated.

What is the FDA product code for Indy OTW Vascular Retriever?

The FDA product code for Indy OTW Vascular Retriever is MMX.

Other Devices by Cook Incorporated

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Related Devices (Code: MMX)

K152136Recovery Cone Removal SystemC.R. Bard, Inc. K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation K163307Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc. K181757Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. K200268Halo Single-Loop Snare KitArgon Medical Devices, 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.