Catalog Number

-

Brand Name

Procedure Products Lines

Version/Model Number

B72-F071

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

K914128,K914128

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

c872940c-a757-43f5-a7ee-ac2a35c68729

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 07, 2017

Package DI Number

B160B72F712

Quantity per Package

25

Contains DI Package

B160B72F711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box