The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Cardiopulmonary Bypass.
| Device ID | K810820 |
| 510k Number | K810820 |
| Device Name: | CARDIOPULMONARY BYPASS |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994646228 | K810820 | 000 |
| 20613994619611 | K810820 | 000 |
| 20613994575405 | K810820 | 000 |
| 20613994575399 | K810820 | 000 |
| 20613994575382 | K810820 | 000 |
| 20613994575375 | K810820 | 000 |
| 20613994575368 | K810820 | 000 |
| 20613994575351 | K810820 | 000 |
| 20613994575337 | K810820 | 000 |
| 20613994619635 | K810820 | 000 |
| 20613994646068 | K810820 | 000 |
| 20613994646075 | K810820 | 000 |
| 20613994646211 | K810820 | 000 |
| 20613994646198 | K810820 | 000 |
| 20613994646174 | K810820 | 000 |
| 20613994646150 | K810820 | 000 |
| 20613994646136 | K810820 | 000 |
| 20613994646129 | K810820 | 000 |
| 20613994646105 | K810820 | 000 |
| 20613994646082 | K810820 | 000 |
| 20613994575313 | K810820 | 000 |