K895041 is an FDA 510(k) clearance for the OPTICAL CATHETER(TM) INTRODUCER SETS. This device is classified as a Accessories, Catheter (Class I - General Controls, product code KGZ).
Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on October 16, 1989, 68 days after receiving the submission on August 9, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K895041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1989 |
| Decision Date | October 16, 1989 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGZ — Accessories, Catheter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |