Cleared Special

K170191 - SilverHawk Peripheral Plaque Excision S...

K170191 is the FDA 510(k) clearance for SilverHawk Peripheral Plaque Excision S... by Medtronic Vascular, Inc.. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Special 510(k) pathway after a 144-day FDA review.

K170191 · Medtronic Vascular, Inc. · Cardiovascular device
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Jun 2017
Decision
144d
Days
Class 2
Risk

K170191 is an FDA 510(k) clearance for the SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Exc.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Medtronic Vascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 16, 2017 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Vascular, Inc. devices

Submission Details

510(k) Number K170191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2017
Decision Date June 16, 2017
Days to Decision 144 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 53
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K170191.
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