Catalog Number

FG00006

Brand Name

XactTS Steerable Transseptal Catheter

Version/Model Number

SS-001

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

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

K202226

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

39c83b9b-00b5-4fee-a25d-72c5968f6938

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

March 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-