Catalog Number

ICAC088105

Brand Name

TracStar™ Large Distal Platform

Version/Model Number

ICAC088105

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"

Yes

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

K180169

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

2e50f11c-1b33-4846-af13-f14a4f5a1bbc

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

April 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-