The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Modified Model Sc4000(f) Cardiotomy Reservoir.
| Device ID | K855049 |
| 510k Number | K855049 |
| Device Name: | MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Michael Frankenburg |
| Correspondent | Michael Frankenburg SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-02-26 |