510(k) Report

Devices descending from K103095

13 later devices reach Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland20260—
+1K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+1K160985Pantera ProBiotronik, Inc.20163—
+1K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.20125—
+2K242969Pantera Pro; Pantera LEOBiotronik, Inc.20241—
+2K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+2K210012Tamarin Blue PTCA RX Dilatation CatheterNatec Medical, Ltd.20210—
+2K163660Pantera LEOBiotronik, Inc.20172—
+2K141933Filao NC RX Ptca Dilatation CatheterNatec Medical, Ltd.20150—
+2K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited20132—
+3K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+3K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited20180—
+3K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited20161—