Catalog Number

-

Brand Name

Indigo System

Version/Model Number

CAT7STR160KIT-A

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

K193595,K210083

Product Code

QEW

Product Code Name

Peripheral Mechanical Thrombectomy With Aspiration

Public Device Record Key

b9d603ae-d30a-49df-9445-34356ca1e011

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

January 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-