K890685 is an FDA 510(k) clearance for the BARD UMBILICAL VESSEL CATHETER. This device is classified as a Catheter, Umbilical Artery (Class II - Special Controls, product code FOS).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on February 28, 1989, 19 days after receiving the submission on February 9, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K890685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1989 |
| Decision Date | February 28, 1989 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FOS — Catheter, Umbilical Artery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |