SOLOPATH Balloon Expandable TransFemoral System

SOLOPATH Balloon Expandable TransFemoral System
SOLOPATH - STFI-1635

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

• Length: 35 Centimeter
• Maximum Rated Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi
• Inner Diameter: 16 FrenchOuter Diameter: 19 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DYB

Device Name: Introducer, Catheter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1340

Third Party Flag: Y

Medical Specialty: CV

Device Id: 50389701012167

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00389701012162

Package Quantity: 39

Package Discontinue Date: 11/15/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton

Device Id: 00389701012162

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A