The following data is part of a premarket notification filed by Usci, Div. C.r. Bard, Inc. with the FDA for Trc Stainless Steel Safety Spring Guides.
Device ID | K772021 |
510k Number | K772021 |
Device Name: | TRC STAINLESS STEEL SAFETY SPRING GUIDES |
Classification | Wire, Guide, Catheter |
Applicant | USCI, DIV. C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-26 |
Decision Date | 1977-11-02 |