Catalog Number

C403-0481

Brand Name

Coeur

Version/Model Number

C403-0481

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K071196,K071196,K071196

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

c88f5217-c238-43b9-b10f-46375add9576

Public Version Date

February 04, 2019

Public Version Number

3

DI Record Publish Date

July 14, 2016

Package DI Number

M297304816

Quantity per Package

2

Contains DI Package

M297304815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper