K030788 is an FDA 510(k) clearance for the KAMAR ANNULUS DILATOR + SIZER. This device is classified as a Dilator, Vessel, Surgical (Class II - Special Controls, product code DWP).
Submitted by Geister Medizin Technik GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on July 12, 2003, 122 days after receiving the submission on March 12, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4475.
| 510(k) Number | K030788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2003 |
| Decision Date | July 12, 2003 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DWP - Dilator, Vessel, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4475 |