Catalog Number

ET309645

Brand Name

EMBOTRAP

Version/Model Number

ET309645

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

K211338

Product Code

NRY

Product Code Name

Catheter, Thrombus Retriever

Public Device Record Key

f5f8a2c2-8bc6-4abf-9574-ff3be149c42b

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

August 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-