Catalog Number

518-043

Brand Name

Turbo-Booster™

Version/Model Number

518-043

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2019

Issuing Agency

In HIBCC

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

4fc92a7d-44ed-4757-85b9-15529b219106

Public Version Date

December 22, 2021

Public Version Number

9

DI Record Publish Date

September 15, 2014

Package DI Number

M2045180431

Quantity per Package

3

Contains DI Package

M2045180430

Package Discontinue Date

February 06, 2019

Package Status

Not in Commercial Distribution

Package Type

Box