K212065 is an FDA 510(k) clearance for the VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on October 7, 2021, 97 days after receiving the submission on July 2, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K212065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2021 |
| Decision Date | October 07, 2021 |
| Days to Decision | 97 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 |