The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Membrane Oxygenator System - Ecmo.
| Device ID | K863476 |
| 510k Number | K863476 |
| Device Name: | SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Michael Frankenberg |
| Correspondent | Michael Frankenberg 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 | 1986-09-09 |
| Decision Date | 1986-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50613994008911 | K863476 | 000 |
| 50613994008898 | K863476 | 000 |