Catalog Number

-

Brand Name

Esperance

Version/Model Number

ASP5F131KIT

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

K211697

Product Code

NRY

Product Code Name

Catheter, Thrombus Retriever

Public Device Record Key

20d6f055-2a9c-4864-83e5-c781cda298ec

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-