ClearanceBrief
510(k) K031842 ยท PDU Catheter For Crossing Total Occlusions

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

ApplicantIntra Luminal Therapeutics, Inc., Carlsbad CA, US
DecisionSubstantially Equivalent, Nov 21, 2003
ReceivedJun 16, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031842

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.