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FDA 510(k)

Indy OTW Vascular Retriever

K-Number: K160593 · 2016-09-02

ApplicantCook Incorporated
Decision Date2016-09-02
Product CodeMMX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Indy OTW Vascular Retriever is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-09-02 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K160593.

When did Indy OTW Vascular Retriever receive FDA 510(k) clearance?

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

Who is the listed applicant for Indy OTW Vascular Retriever?

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

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

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

Other records listing Cook Incorporated as applicant

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Related Devices (Code: MMX)

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.

K242776LimFlow V-CeiverLimFlow, Inc.K241259Amplatz Goose Neck Snare KitMedtronic, Inc.K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.K222254Gunther Tulip Vena Cava Filter Retrieval SetCook IncorporatedK222083LimFlow V-CeiverLimFlow, Inc.K212988ONO Retrieval DeviceOnocor Vascular, LLC

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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