The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Model Sm-c/vr Cardiotomy/venous Reservoir.
| Device ID | K882380 |
| 510k Number | K882380 |
| Device Name: | SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Swanson Lano |
| Correspondent | Swanson Lano SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-09 |
| Decision Date | 1988-10-06 |