Catalog Number

-

Brand Name

Angel Catheter

Version/Model Number

AC3930A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K160747,K160747

Product Code

PNS

Product Code Name

Short-Term Intravascular Filter Catheter

Public Device Record Key

f34280b3-db7e-4da0-8164-59bbc2990ca6

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

25711055005009

Quantity per Package

5

Contains DI Package

15711055005002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-