Catalog Number

D134402

Brand Name

CARTO 3 System eco Interface Cable

Version/Model Number

D134402

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

K193237

Product Code

MTD

Product Code Name

Catheter, intracardiac mapping, high-density array

Public Device Record Key

82161d21-2cf4-4385-9b4a-9178b412b3fb

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

July 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-