The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Myotherm (tm) Xp Cardioplegia Delivery System.
| Device ID | K971105 |
| 510k Number | K971105 |
| Device Name: | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | AVECOR CARDIOVASCULAR, INC. 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Dennis E Steger |
| Correspondent | Dennis E Steger AVECOR CARDIOVASCULAR, INC. 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-26 |
| Decision Date | 1997-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994947752 | K971105 | 000 |
| 20613994947745 | K971105 | 000 |
| 50613994010327 | K971105 | 000 |