The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Mullins Transseptal Catheter Intro..
| Device ID | K791963 |
| 510k Number | K791963 |
| Device Name: | USCI MULLINS TRANSSEPTAL CATHETER INTRO. |
| Classification | Introducer, Catheter |
| Applicant | 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 | 1979-10-01 |
| Decision Date | 1979-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169021303 | K791963 | 000 |
| 00643169014763 | K791963 | 000 |
| 00643169014756 | K791963 | 000 |
| 00643169014749 | K791963 | 000 |
| 00643169014732 | K791963 | 000 |
| 00643169014725 | K791963 | 000 |
| 00643169014718 | K791963 | 000 |