The following data is part of a premarket notification filed by Usci, Div. C.r. Bard, Inc. with the FDA for 888 Arterial/venous Catheter Introducer.
Device ID | K771982 |
510k Number | K771982 |
Device Name: | 888 ARTERIAL/VENOUS CATHETER INTRODUCER |
Classification | Introducer, Catheter |
Applicant | USCI, DIV. C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-18 |
Decision Date | 1977-11-02 |