The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Maxima* Collapsible Venous Reservoir Bag & Holder.
| Device ID | K873423 |
| 510k Number | K873423 |
| Device Name: | MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Contact | Denise A Carpenter |
| Correspondent | Denise A Carpenter 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 | 1987-08-25 |
| Decision Date | 1987-11-06 |