Catalog Number

-

Brand Name

AngioDynamics

Version/Model Number

25185

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

K142593

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

9e8208ad-0b3f-43b9-80bf-a8874d36f7d5

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-