The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Griffith Tdmac Heparinized Veno-venous Shun.
| Device ID | K850917 |
| 510k Number | K850917 |
| Device Name: | ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-05-21 |