Catalog Number

-

Brand Name

Indigo System

Version/Model Number

CAT3KIT-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

K121917

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

dbf28767-bd47-487e-9896-1ba63cf533d2

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

January 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-