Catalog Number

518-043

Brand Name

Turbo-Booster™

Version/Model Number

518-043AA

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

K071226,K071226

Product Code

PDU

Product Code Name

Catheter For Crossing Total Occlusions

Public Device Record Key

f95e4d45-6eb7-41d7-88d1-ae2075fd1922

Public Version Date

December 22, 2021

Public Version Number

8

DI Record Publish Date

February 06, 2015

Package DI Number

20813132020273

Quantity per Package

3

Contains DI Package

00813132020279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box