The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Intersept* Cardiotomy Reservoir With Filter.
| Device ID | K864895 |
| 510k Number | K864895 |
| Device Name: | INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Contact | James J Brennan |
| Correspondent | James J Brennan JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-02-19 |