The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Extracorporeal Blood Gas System.
Device ID | K822000 |
510k Number | K822000 |
Device Name: | EXTRACORPOREAL BLOOD GAS SYSTEM |
Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
Applicant | CARDIOVASCULAR DEVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTY |
CFR Regulation Number | 870.4410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-07 |
Decision Date | 1982-12-22 |