Catalog Number

IMP-FX-12

Brand Name

IMPEDE-FX Embolization Plug

Version/Model Number

IMP-FX-12

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 12, 2021

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

K182390

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Public Device Record Key

078d49ff-92b6-4974-8d91-94597adeda35

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

October 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-