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 |