Catalog Number

ICAC088095

Brand Name

TracStar™ Large Distal Platform

Version/Model Number

ICAC088095

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

K212224

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

44d40354-cc72-41eb-9f9d-ef6bbcf70803

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-