The following data is part of a premarket notification filed by Usci, Div. C.r. Bard, Inc. with the FDA for Debakey Vasculour-d Prostheses.
Device ID | K770235 |
510k Number | K770235 |
Device Name: | DEBAKEY VASCULOUR-D PROSTHESES |
Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Applicant | USCI, DIV. C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSY |
CFR Regulation Number | 870.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-07 |
Decision Date | 1977-02-24 |