K043423 is an FDA 510(k) clearance for the MODEL SC-3008 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 February 1, 2005, 50 days after receiving the submission on December 13, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K043423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2004 |
| Decision Date | February 01, 2005 |
| 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 |