K940871 is an FDA 510(k) clearance for the UMBILI-CATH-P. This device is classified as a Catheter, Umbilical Artery (Class II - Special Controls, product code FOS).
Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on April 29, 1994, 63 days after receiving the submission on February 25, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K940871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1994 |
| Decision Date | April 29, 1994 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FOS — Catheter, Umbilical Artery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |