Graft, Vascular, Stainless Steel Tunneler

Device Code: 896

Product Code(s): MZY

Device Classification Information

• Device Type ID: 896
• Device Name: Graft, Vascular, Stainless Steel Tunneler
• Regulation Description: Vascular Graft Prosthesis.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Diagnostics Devices Branch (CDDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 870.3450 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MZY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 896
• Device: Graft, Vascular, Stainless Steel Tunneler
• Product Code: MZY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Vascular Graft Prosthesis.
• CFR Regulation Number: 870.3450 [🔎]

Device Problems
Detachment Of Device Or Device Component	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:44:33