K944367 is an FDA 510(k) clearance for the CATCO POLYURETHANE UMBILICAL VESSEL CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 5, 1995, 210 days after receiving the submission on September 7, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K944367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1994 |
| Decision Date | April 05, 1995 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |