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FDA 510(k)

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter

K-Number: K162448 · 2017-05-26

ApplicantCook Incorporated
Decision Date2017-05-26
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K162448. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter?

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Cook Incorporated. The 510(k) number is K162448.

When did White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter receive FDA 510(k) clearance?

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter received FDA 510(k) clearance on 2017-05-26, under 510(k) number K162448.

Who is the listed applicant for White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter?

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 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter?

The FDA product code for White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter is DQO.

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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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