The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Cardiopulminary Bypass Catheter Cannula.
| Device ID | K810548 |
| 510k Number | K810548 |
| Device Name: | CARDIOPULMINARY BYPASS CATHETER CANNULA |
| 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 | 1981-03-02 |
| Decision Date | 1981-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994374899 | K810548 | 000 |
| 20613994495505 | K810548 | 000 |
| 20613994495444 | K810548 | 000 |
| 20613994495406 | K810548 | 000 |
| 20613994495390 | K810548 | 000 |
| 20613994495383 | K810548 | 000 |
| 20613994495352 | K810548 | 000 |
| 20613994495338 | K810548 | 000 |
| 20613994495321 | K810548 | 000 |
| 20613994495307 | K810548 | 000 |
| 20613994495529 | K810548 | 000 |
| 20613994495543 | K810548 | 000 |
| 00643169695948 | K810548 | 000 |
| 00673978861579 | K810548 | 000 |
| 00673978861562 | K810548 | 000 |
| 00673978861555 | K810548 | 000 |
| 20613994736691 | K810548 | 000 |
| 20613994736677 | K810548 | 000 |
| 20613994495666 | K810548 | 000 |
| 20613994495574 | K810548 | 000 |
| 20613994495550 | K810548 | 000 |
| 00763000192419 | K810548 | 000 |