The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Catheter Two Stage Venous Return.
| Device ID | K915268 |
| 510k Number | K915268 |
| Device Name: | CATHETER TWO STAGE VENOUS RETURN |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Roger W.brink |
| Correspondent | Roger W.brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. 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 | 1991-11-25 |
| Decision Date | 1992-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994887416 | K915268 | 000 |
| 20613994887140 | K915268 | 000 |
| 20613994887300 | K915268 | 000 |
| 20613994887317 | K915268 | 000 |
| 20613994887348 | K915268 | 000 |
| 20613994887355 | K915268 | 000 |
| 20613994887409 | K915268 | 000 |
| 20613994887447 | K915268 | 000 |
| 20613994887454 | K915268 | 000 |
| 20613994887485 | K915268 | 000 |
| 20613994887492 | K915268 | 000 |
| 20613994887522 | K915268 | 000 |
| 20613994887539 | K915268 | 000 |
| 00643169114500 | K915268 | 000 |
| 00643169114517 | K915268 | 000 |
| 00643169114524 | K915268 | 000 |
| 00643169114531 | K915268 | 000 |
| 20613994887102 | K915268 | 000 |