PS ASC
TrailBlazer™ - ASC-035-150
Device Description
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Environmental Conditions
- Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Device Sizes
- Catheter Working Length: 150.0 Centimeter
- Guidewire compatibility 0.89 MM
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DQY
Device Name: Catheter, Percutaneous
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: 870.1250
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 20763000770383
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00763000770389
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PK
Device Id: 00763000770389
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