The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Picso Cannula, Catalog Code 94315.
| Device ID | K897022 |
| 510k Number | K897022 |
| Device Name: | PICSO CANNULA, CATALOG CODE 94315 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Chet Vanhof |
| Correspondent | Chet Vanhof 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 | 1989-12-19 |
| Decision Date | 1990-03-16 |