Submission Details
| 510(k) Number | K212065 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
Oct 2021
Decision
97d
Days
Class 2
Risk
About This 510(k) Submission
K212065 is an FDA 510(k) clearance for the VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger, 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 review panel. Regulated under 21 CFR 870.2100.
Device Classification
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2100 |
Manufacturer
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