K904558 is an FDA 510(k) clearance for the DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 11, 1991, 129 days after receiving the submission on October 5, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K904558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | October 05, 1990 |
| Decision Date | February 11, 1991 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |