Catalog Number

H702518

Brand Name

TactiCath™ Ablation Catheter, Sensor Enabled™

Version/Model Number

H702518

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

K201181

Product Code

OAE

Product Code Name

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

Public Device Record Key

b43f4572-fb1c-4efe-942c-c7fed6436116

Public Version Date

July 30, 2020

Public Version Number

1

DI Record Publish Date

July 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-