K211589 is an FDA 510(k) clearance for the VascuChek Kit, VascuChek Transceiver, VascuChek Surgical 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 January 27, 2022, 248 days after receiving the submission on May 24, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K211589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2021 |
| Decision Date | January 27, 2022 |
| Days to Decision | 248 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 |