Catalog Number

A4E02

Brand Name

Syntel Silicone OTW Embolectomy Catheter

Version/Model Number

A4E02

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K970762

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

3efeb3a8-1058-4f0e-8281-b4345e01f05d

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-