K030589 is an FDA 510(k) clearance for the MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS. 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 May 21, 2003, 85 days after receiving the submission on February 25, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K030589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2003 |
| Decision Date | May 21, 2003 |
| Days to Decision | 85 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 |