← Back to catalogue

SilverHawk™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
SilverHawk™ FDA UDI
Generic Name
Mechanical atherectomy system catheter, peripheral FDA UDI
Device Name
ATHERECTOMY P4028 DS SILVERHAWK BTK UNI FDA UDI
Model / Reference
P4028 FDA UDI
Description
ATHERECTOMY P4028 DS SILVERHAWK BTK UNI FDA UDI

Identifiers

Primary DI / UDI-DI
00643169968455 FDA UDI
510(k) Number
K170191 FDA UDI
FDA Product Code
MCW FDA UDI
GMDN Term
Mechanical atherectomy system catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.9 Millimeter FDA UDI
Catheter Gauge — 6.0 French FDA UDI
Length — 132.0 Centimeter FDA UDI

Category: Mechanical atherectomy system catheter, peripheral

SilverHawk™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system catheter, peripheral.

Cleared under the same submission

K170191 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 7d815837-27ac-4d52-aae1-5f9e4419a93e 37 fields · synced May 30, 2026