VALVE T510C31 HKII MIT CINCH US

VALVE T510C31 HKII MIT CINCH US
HANCOCK® II - T510C31

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

• Valve Size 31 MM

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LWR

Device Name: Heart-Valve, Non-Allograft Tissue

Device Class: 3

Physical State: N/A

Definition: N/A

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: N/A

Third Party Flag: N

Medical Specialty: N/A

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 Id: 00613994686824

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