The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Cdi(tm) Extracorporeal Blood Gas System 300.
| Device ID | K871221 |
| 510k Number | K871221 |
| Device Name: | CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Contact | Steven Arick |
| Correspondent | Steven Arick CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine, CA 92714 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-06-05 |