Catalog Number

-

Brand Name

Procedure products lines

Version/Model Number

P12-R187

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

1cac1155-a0a4-47b1-9500-9991bdde409c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 03, 2017

Package DI Number

B160P12R1872

Quantity per Package

25

Contains DI Package

B160P12R1871

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box