SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System

Basic Information

• Brand Name: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
• Primary DI: 08600035053037
• Version / Model: 3003
• Catalog Number: 3003
• Company Name: East End Medical I LLC
• Labeler DUNS: 118148023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-13
• Public Version: 2
• Public Version Date: 2023-02-24
• Public Version Status: Update
• Public Device Record Key: eb630426-236a-4ea1-b6f2-c744abbe03fb
• Distribution End Date: 2025-05-30

Device Description

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Large size.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10747	Cardiac septostomy catheter, balloon	A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device.	No	Active
65312	Cardiovascular catheter sheath	A sterile, noninvasive, flexible sleeve intended to be used during cardiovascular catheterization (e.g., femoral, pulmonary) to cover and protect the exposed proximal end of a cardiovascular catheter to prevent contamination (extending the sterile field of the external catheter) and/or to contain a backflow of blood (e.g., during catheter introduction, repositioning or removal). It is typically transparent and includes appropriate connectors for distal attachment to the catheter introducer, and proximal attachment to the extracorporeal portion of the catheter. Neither the catheter nor introduction/procedural devices are included (i.e., not a set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08600035053037	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203459	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 109 KiloPascal