K914315 is an FDA 510(k) clearance for the OPTICAL CATHETER INTRODUCER SETS, MODIFICATION. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 4, 1992, 181 days after receiving the submission on September 5, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K914315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1991 |
| Decision Date | March 04, 1992 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |