Catalog Number

3001

Brand Name

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System

Version/Model Number

3001

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"

Yes

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

K203459

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

edadb073-5845-45c0-bd8f-b67c73d0ca54

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-