The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Aortic Root Cannula.
| Device ID | K790565 |
| 510k Number | K790565 |
| Device Name: | AORTIC ROOT CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-19 |
| Decision Date | 1979-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169695955 | K790565 | 000 |
| 20613994540182 | K790565 | 000 |
| 20613994540168 | K790565 | 000 |
| 20613994540151 | K790565 | 000 |
| 20613994540144 | K790565 | 000 |
| 20613994540120 | K790565 | 000 |
| 20613994495499 | K790565 | 000 |
| 20613994495482 | K790565 | 000 |
| 20613994495468 | K790565 | 000 |
| 20613994495451 | K790565 | 000 |
| 20613994540199 | K790565 | 000 |
| 20613994540212 | K790565 | 000 |
| 00673978861494 | K790565 | 000 |
| 00673978861487 | K790565 | 000 |
| 00673978861425 | K790565 | 000 |
| 00673978861418 | K790565 | 000 |
| 20613994676140 | K790565 | 000 |
| 20613994676126 | K790565 | 000 |
| 20613994540267 | K790565 | 000 |
| 20613994540250 | K790565 | 000 |
| 20613994540236 | K790565 | 000 |
| 00763000192389 | K790565 | 000 |