ClearanceBrief
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

ApplicantVenous Health Systems, Inc., Portola Valley CA, US
DecisionSubstantially Equivalent, Dec 21, 2012
ReceivedAug 27, 2012
TypeTraditional
FDA recordOpen 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.