K884337 is an FDA 510(k) clearance for the MICRO-GUIDE SYSTEM. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Catheter Research C/O Burditt, Bowles & Radzius (Chicago, US). The FDA issued a Cleared decision on January 5, 1989, 83 days after receiving the submission on October 14, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K884337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1988 |
| Decision Date | January 05, 1989 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |