The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pul,monary Artery Vent Catheter.
| Device ID | K845046 |
| 510k Number | K845046 |
| Device Name: | PUL,MONARY ARTERY VENT CATHETER |
| 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 | 1984-12-28 |
| Decision Date | 1985-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994742388 | K845046 | 000 |