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 |