K081680 is an FDA 510(k) clearance for the NUCLEUS-X, MODEL 230X. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on July 10, 2008, 23 days after receiving the submission on June 17, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K081680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2008 |
| Decision Date | July 10, 2008 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |