The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Minimax (tm) Collapsible Venous Reservoir Bag.
| Device ID | K911790 |
| 510k Number | K911790 |
| Device Name: | MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Norma L.lowe |
| Correspondent | Norma L.lowe MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-08-12 |