CONDUIT HC150
HANCOCK® - HC150-14
Device Description
An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).
Environmental Conditions
- 25.00
- 5.00
Device Sizes
- Valve Size 14 MM
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DYE
Device Name: Replacement Heart-Valve
Device Class: 3
Physical State: N/A
Definition: Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Submission Type ID: 2
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: Y
Target Area: N/A
Regulation Number: 870.3925
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00681490908740
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
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