FDA 510(k)

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

Numéro K : K170191 · 2017-06-16

Date de décision2017-06-16

Code produitMCW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K170191. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K170191.

When did SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System receive FDA 510(k) clearance?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K170191.

Who is the listed applicant for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

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

What is the FDA product code for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

The FDA product code for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is MCW.

Essais cliniques associés

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Dispositifs connexes (Code : MCW)

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Source officielle

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