K211235 is an FDA 510(k) clearance for the CIRCUL8 Luxe DVT Prevention Device. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Ortho8, Inc. (Rocklin, US). The FDA issued a Cleared decision on September 8, 2021, 135 days after receiving the submission on April 26, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K211235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2021 |
| Decision Date | September 08, 2021 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |