Catalog Number

A088049

Brand Name

Therapy™

Version/Model Number

Cool Path SP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

P060019

Product Code

OAD

Product Code Name

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Public Device Record Key

9f0c5148-bfc6-4b2e-8806-20836200f1fc

Public Version Date

May 01, 2020

Public Version Number

4

DI Record Publish Date

September 29, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-