The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Pruitt-vascular Shunts.
| Device ID | K850356 |
| 510k Number | K850356 |
| Device Name: | PRUITT-VASCULAR SHUNTS |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | IDEAS FOR MEDICINE, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul IDEAS FOR MEDICINE, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-02-27 |