The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Silicone Left Ventricular And.
| Device ID | K843444 |
| 510k Number | K843444 |
| Device Name: | ARGYLE SILICONE LEFT VENTRICULAR AND |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
| Contact | Frank J Fuchile |
| Correspondent | Frank J Fuchile SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-05 |
| Decision Date | 1984-10-18 |