K142640 is an FDA 510(k) clearance for the Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on November 6, 2014, 50 days after receiving the submission on September 17, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K142640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2014 |
| Decision Date | November 06, 2014 |
| Days to Decision | 50 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 |