The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Coronary Pressure Perfusion Pump.
Device ID | K771764 |
510k Number | K771764 |
Device Name: | CORONARY PRESSURE PERFUSION PUMP |
Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXS |
CFR Regulation Number | 870.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-19 |
Decision Date | 1977-09-30 |