The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Ii Membrane Oxygenator System.
| Device ID | K843956 |
| 510k Number | K843956 |
| Device Name: | SCIMED II MEMBRANE OXYGENATOR SYSTEM |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Michael T Frankenbe |
| Correspondent | Michael T Frankenbe SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1985-01-08 |