K183438 is an FDA 510(k) clearance for the Geomed Vascular Dilators. This device is classified as a Dilator, Vessel, Surgical (Class II - Special Controls, product code DWP).
Submitted by Geomed Medizin-Technik GmbH & Co. (Tuttlingen, DE). The FDA issued a Cleared decision on September 3, 2019, 265 days after receiving the submission on December 12, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4475.
| 510(k) Number | K183438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2018 |
| Decision Date | September 03, 2019 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWP - Dilator, Vessel, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4475 |