510(k) Report

Devices descending from K112513

3 later devices reach Ebony Pta 0.014 Peripheral Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+1K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+1K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—