The following data is part of a premarket notification filed by 3m Company with the FDA for Modified Mp-4 Cardioplegia Delivery System W/condu.
| Device ID | K900640 |
| 510k Number | K900640 |
| Device Name: | MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | James Balun |
| Correspondent | James Balun 3M COMPANY 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00699753506459 | K900640 | 000 |
| 00699753506442 | K900640 | 000 |
| 50699753008538 | K900640 | 000 |
| 50699753008521 | K900640 | 000 |
| 50699753002949 | K900640 | 000 |
| 50699753000273 | K900640 | 000 |