The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Vascular Bypass Set.
Device ID | K871844 |
510k Number | K871844 |
Device Name: | ARGYLE VASCULAR BYPASS SET |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Frank S Morrison |
Correspondent | Frank S Morrison 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 | 1987-05-08 |
Decision Date | 1987-08-03 |