Catalog Number

GC595BUJB

Brand Name

Chaperon Guiding Catheter

Version/Model Number

GC595BUJB

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"

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

K082385

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

1b47baf4-afe4-4c0f-b57a-f5d44f5e0fd1

Public Version Date

December 22, 2021

Public Version Number

10

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-