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HawkOne™

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
HawkOne™ FDA UDI
Generic Name
Mechanical atherectomy system catheter, peripheral FDA UDI
Device Name
ATHERECTOMY H1-M US HAWKONE V01 FDA UDI
Model / Reference
H1-M FDA UDI
Description
ATHERECTOMY H1-M US HAWKONE V01 FDA UDI

Identifiers

Primary DI / UDI-DI
00643169728769 FDA UDI
510(k) Number
K161361 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

No

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
Length — 129.0 Centimeter FDA UDI
Outer Diameter — 2.2 Millimeter FDA UDI
Catheter Gauge — 6.0 French FDA UDI

Category: Mechanical atherectomy system catheter, peripheral

HawkOne™ by Covidien LP — 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

K161361 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 3dc49294-a88a-4549-a604-f7759d7d5ff2 37 fields · synced May 30, 2026