Catalog Number

C453-2420

Brand Name

Coeur/Nemoto

Version/Model Number

C453-2420

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

372058fa-bda4-4e17-84ef-bf385653578e

Public Version Date

September 28, 2018

Public Version Number

1

DI Record Publish Date

August 28, 2018

Package DI Number

M902124206

Quantity per Package

2

Contains DI Package

M902124205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper