510(k) Report

Devices descending from K103354

2 later devices reach Ebony Pta .035 Peripheral Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+1K143036Ebony PTA 0.035 Peripheral Dilatation CatheterNatec Medical, Ltd.20150—