K864943 is an FDA 510(k) clearance for the NUMED BALLOON WEDGE PRESSURE CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on February 20, 1987, 65 days after receiving the submission on December 17, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K864943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1986 |
| Decision Date | February 20, 1987 |
| Days to Decision | 65 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 |