Cleared Special

K170191 - SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

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

K170191 · Medtronic Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K170191

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

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 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K170191.
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K172687 · Spectranetics, Inc. · Nov 2017
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
K172236 · Avinger, Inc. · Oct 2017
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
K172386 · Volcano Atheromed, Inc. · Aug 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · Cardiovascular Systems, Inc. · Jun 2017
Spectranetics Turbo-Elite Laser Atherectomy Catheters
K170059 · Spectranetics, Inc. · Apr 2017
Turbo-Power (2.0mm) Laser Atherectomy Catheters
K162561 · Spectranetics, Inc. · Jan 2017
K170191 · SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
Download PDF FDA Summary Medtronic Vascular, I…