Catalog Number

-

Brand Name

TurboHawk™

Version/Model Number

THS-SX-C

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103618

Product Code

MCW

Product Code Name

Catheter, peripheral, atherectomy

Public Device Record Key

d3afa39e-534e-4afa-a26f-653040454bc1

Public Version Date

July 23, 2018

Public Version Number

1

DI Record Publish Date

June 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-