SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

Catheter, Peripheral, Atherectomy

MEDTRONIC VASCULAR, INC.

The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Silverhawk Peripheral Plaque Excision System, Turbohawk Peripheral Plaque Excision System.

Pre-market Notification Details

Device IDK170191
510k NumberK170191
Device Name:SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
ClassificationCatheter, Peripheral, Atherectomy
Applicant MEDTRONIC VASCULAR, INC. 3033 CAMPUS DRIVE Plymouth,  MN  55441
ContactAaron Hage
CorrespondentAaron Hage
MEDTRONIC VASCULAR, INC. 3033 CAMPUS DRIVE Plymouth,  MN  55441
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-23
Decision Date2017-06-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169968547 K170191 000
00643169968226 K170191 000
00643169968400 K170191 000
00643169968424 K170191 000
00643169968431 K170191 000
00643169968448 K170191 000
00643169968455 K170191 000
00643169968462 K170191 000
00643169968479 K170191 000
00643169968202 K170191 000

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