The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Ecmotherm(tm) Heat Exchanger.
| Device ID | K884560 |
| 510k Number | K884560 |
| Device Name: | SCIMED ECMOTHERM(TM) HEAT EXCHANGER |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Contact | Swanson Lano |
| Correspondent | Swanson Lano SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-31 |
| Decision Date | 1989-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994009647 | K884560 | 000 |
| 00613994008701 | K884560 | 000 |
| 30613994009648 | K884560 | 000 |
| 30613994008702 | K884560 | 000 |