ClearanceBrief
510(k) K001958 ยท MPB Catheter, Hemodialysis, Non-Implanted

KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH

ApplicantKeystone Medical, Great Neck NY, US
DecisionSubstantially Equivalent, Sep 25, 2000
ReceivedJun 27, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K001958

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.