K870700 is an FDA 510(k) clearance for the MICRO-GUIDE. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Catheter Research C/O Burditt, Bowles & Radzius (Chicago, US). The FDA issued a Cleared decision on December 3, 1987, 287 days after receiving the submission on February 19, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K870700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1987 |
| Decision Date | December 03, 1987 |
| Days to Decision | 287 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |