The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Clear Cardioplejia Delivery System.
| Device ID | K823451 |
| 510k Number | K823451 |
| Device Name: | CLEAR CARDIOPLEJIA DELIVERY SYSTEM |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-17 |
| Decision Date | 1983-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753506775 | K823451 | 000 |
| 50699753515494 | K823451 | 000 |
| 00699753515505 | K823451 | 000 |
| 50699753515371 | K823451 | 000 |
| 50699753001362 | K823451 | 000 |
| 50699753001386 | K823451 | 000 |
| 50699753001539 | K823451 | 000 |
| 50699753001546 | K823451 | 000 |
| 00699753505681 | K823451 | 000 |
| 00699753506466 | K823451 | 000 |
| 50699753506676 | K823451 | 000 |
| 50699753506713 | K823451 | 000 |
| 00699753506725 | K823451 | 000 |
| 50699753515487 | K823451 | 000 |