Catalog Number

18-5033

Brand Name

HeartLight

Version/Model Number

18-5033

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

-

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

P150026

Product Code

OAE

Product Code Name

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Public Device Record Key

4b98c806-ebe6-4eed-afaa-44502e138ea7

Public Version Date

May 27, 2020

Public Version Number

1

DI Record Publish Date

May 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-