Catalog Number

-

Brand Name

HawkOne™

Version/Model Number

H1-M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161361

Product Code

MCW

Product Code Name

Catheter, peripheral, atherectomy

Public Device Record Key

3dc49294-a88a-4549-a604-f7759d7d5ff2

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-