K052209 is an FDA 510(k) clearance for the VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Vascular Control Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 6, 2005, 22 days after receiving the submission on August 15, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K052209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2005 |
| Decision Date | September 06, 2005 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |