K831988 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER. This device is classified as a Catheter, Umbilical Artery (Class II - Special Controls, product code FOS).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on November 8, 1983, 140 days after receiving the submission on June 21, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K831988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1983 |
| Decision Date | November 08, 1983 |
| Days to Decision | 140 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 |