Holder, Heart-valve, Prosthesis

Device Code: 787

Product Code(s): DTJ

Device Classification Information

• Device Type ID: 787
• Device Name: Holder, Heart-valve, Prosthesis
• Regulation Description: Prosthetic Heart Valve Holder.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Structural Heart Devices Branch (SHDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 870.3935 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DTJ
• 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: 787
• Device: Holder, Heart-valve, Prosthesis
• Product Code: DTJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Prosthetic Heart Valve Holder.
• CFR Regulation Number: 870.3935 [🔎]

TPLC Last Update: 2019-04-02 19:41:31