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FDA 510(k)

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

K-Number: K170191 · 2017-06-16

ApplicantMedtronic Vascular, Inc.
Decision Date2017-06-16
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Medtronic Vascular, Inc.. The 510(k) number is K170191.

When was SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System approved by the FDA?

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

What company makes SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is manufactured by Medtronic Vascular, Inc..

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.

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Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

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Related Devices (Code: MCW)

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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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