Catalog Number

IK52221

Brand Name

Valved Introducer

Version/Model Number

Flowguard

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"

Yes

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

8feff5e1-06c2-43ef-84b8-5ecfb8dda4f0

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

M991IK522212

Quantity per Package

2

Contains DI Package

M991IK522211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box