The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Percutaneous Arterial/venous Cannula Placement Kit.
| Device ID | K875353 |
| 510k Number | K875353 |
| Device Name: | PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Van Hof |
| Correspondent | Van Hof 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 | 1987-12-31 |
| Decision Date | 1988-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994557100 | K875353 | 000 |
| 20613994556824 | K875353 | 000 |
| 20643169485871 | K875353 | 000 |
| 20643169485888 | K875353 | 000 |
| 20643169485895 | K875353 | 000 |
| 00673978861623 | K875353 | 000 |
| 00673978861630 | K875353 | 000 |
| 00673978861647 | K875353 | 000 |
| 00673978861654 | K875353 | 000 |
| 20613994556817 | K875353 | 000 |
| 20613994556800 | K875353 | 000 |
| 00763000946494 | K875353 | 000 |
| 00763000192426 | K875353 | 000 |
| 20613994556701 | K875353 | 000 |
| 20613994556718 | K875353 | 000 |
| 20613994556763 | K875353 | 000 |
| 20613994556770 | K875353 | 000 |
| 20613994556787 | K875353 | 000 |
| 20613994556794 | K875353 | 000 |
| 00673978861661 | K875353 | 000 |
| 00673978861678 | K875353 | 000 |
| 00643169560703 | K875353 | 000 |
| 00643169560710 | K875353 | 000 |
| 00643169697560 | K875353 | 000 |
| 00643169697577 | K875353 | 000 |
| 00613994556721 | K875353 | 000 |
| 00613994556738 | K875353 | 000 |
| 00613994556745 | K875353 | 000 |
| 00613994556752 | K875353 | 000 |
| 00643169486706 | K875353 | 000 |
| 00643169486690 | K875353 | 000 |
| 00673978864907 | K875353 | 000 |
| 00673978864914 | K875353 | 000 |
| 00673978864921 | K875353 | 000 |
| 00673978864938 | K875353 | 000 |
| 00673978864952 | K875353 | 000 |
| 00681490550406 | K875353 | 000 |
| 00643169263079 | K875353 | 000 |
| 00643169486683 | K875353 | 000 |
| 00763000946487 | K875353 | 000 |