Catalog Number

-

Brand Name

ASAHI Corsair Armet 18

Version/Model Number

CSAR135-18N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K202252

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

cb6faf84-576b-4f38-a045-1582ea351d32

Public Version Date

January 25, 2022

Public Version Number

2

DI Record Publish Date

September 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-