The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Models P-7-14 And A-19-38 Heat Exchangers.
| Device ID | K880451 |
| 510k Number | K880451 |
| Device Name: | SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS |
| Classification | Heat-exchanger, 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 | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-02 |
| Decision Date | 1988-04-28 |