Catalog Number

-

Brand Name

Indigo System

Version/Model Number

SEP7-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

K210083

Product Code

QEW

Product Code Name

Peripheral Mechanical Thrombectomy With Aspiration

Public Device Record Key

54f03c5e-1bbb-45da-8768-7a7bb0b8075a

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

February 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-