The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Submission Coronary Cannula.
| Device ID | K821149 |
| 510k Number | K821149 |
| Device Name: | SUBMISSION CORONARY 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 | 1982-04-23 |
| Decision Date | 1982-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994576044 | K821149 | 000 |
| 20613994575955 | K821149 | 000 |
| 20613994575962 | K821149 | 000 |
| 20613994575979 | K821149 | 000 |
| 20613994575986 | K821149 | 000 |
| 20613994575993 | K821149 | 000 |
| 20613994576006 | K821149 | 000 |
| 20613994576013 | K821149 | 000 |
| 20613994576020 | K821149 | 000 |
| 20613994576037 | K821149 | 000 |
| 20613994575948 | K821149 | 000 |