The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Tapered Vascular Shunt.
Device ID | K840914 |
510k Number | K840914 |
Device Name: | ARGYLE TAPERED VASCULAR SHUNT |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-29 |
Decision Date | 1984-04-17 |