The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Intracardiac Sump 12010.
| Device ID | K850385 |
| 510k Number | K850385 |
| Device Name: | INTRACARDIAC SUMP 12010 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Contact | Ronald A Williams |
| Correspondent | Ronald A Williams DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994619277 | K850385 | 000 |
| 20613994619260 | K850385 | 000 |
| 20613994619246 | K850385 | 000 |
| 20613994619239 | K850385 | 000 |
| 20613994619215 | K850385 | 000 |