The following data is part of a premarket notification filed by Usci, Div. C.r. Bard, Inc. with the FDA for Usci Input Introducer Set.
| Device ID | K940092 |
| 510k Number | K940092 |
| Device Name: | USCI INPUT INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | USCI, DIV. C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Contact | Janet D Benson |
| Correspondent | Janet D Benson USCI, DIV. C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1995-08-10 |