The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Aortic Root Cannula W/integral Press.
| Device ID | K831591 |
| 510k Number | K831591 |
| Device Name: | AORTIC ROOT CANNULA W/INTEGRAL PRESS |
| 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 | 1983-05-17 |
| Decision Date | 1983-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994918608 | K831591 | 000 |
| 20613994918585 | K831591 | 000 |
| 20613994900412 | K831591 | 000 |
| 20613994540090 | K831591 | 000 |
| 20613994495420 | K831591 | 000 |