Catalog Number

-

Brand Name

Indigo Aspiration System

Version/Model Number

IAPS3-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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180105

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

a7b5c151-4b0d-4916-b76c-8b8c2d109845

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-