K942315 is an FDA 510(k) clearance for the NAVARRE PERCUTANEOUS ACCESS SET. This device is classified as a Accessories, Catheter (Class I - General Controls, product code KGZ).
Submitted by Navarre Biomedical , Ltd. (Hamel, US). The FDA issued a Cleared decision on July 8, 1994, 56 days after receiving the submission on May 13, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K942315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1994 |
| Decision Date | July 08, 1994 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGZ — Accessories, Catheter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |