The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci(r) Access(tm) Introducer Set.
| Device ID | K901452 |
| 510k Number | K901452 |
| Device Name: | USCI(R) ACCESS(TM) INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Contact | Anne M Kulis |
| Correspondent | Anne M Kulis C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-05-22 |