Catalog Number

-

Brand Name

Indigo System

Version/Model Number

CAT12HTORQ100KIT-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

K192981

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

7162de50-1222-440a-b732-a1bbdf0c1240

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-