510(k) K122609 ยท JOW Sleeve, Limb, Compressible
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
| Applicant | Venous Health Systems, Inc., Portola Valley CA, US |
| Decision | Substantially Equivalent, Dec 21, 2012 |
| Received | Aug 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122609
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.