K121859 is an FDA 510(k) clearance for the TYSHAK NUCLEUS. 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 August 31, 2012, 66 days after receiving the submission on June 26, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K121859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2012 |
| Decision Date | August 31, 2012 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |