The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Extracorpeal Cardiotomy Blood Filter.
| Device ID | K780653 |
| 510k Number | K780653 |
| Device Name: | EXTRACORPEAL CARDIOTOMY BLOOD FILTER |
| Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOD |
| CFR Regulation Number | 870.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-19 |
| Decision Date | 1978-06-14 |