The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Oxygenator Gas Line Filter.
| Device ID | K792151 |
| 510k Number | K792151 |
| Device Name: | OXYGENATOR GAS LINE FILTER |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | CARDIO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-22 |
| Decision Date | 1979-11-13 |