K913235 is an FDA 510(k) clearance for the DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1991, 101 days after receiving the submission on July 22, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K913235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1991 |
| Decision Date | October 31, 1991 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |