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KANEKA Corporation

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest FDA decision2018-03-19
TypeNumberDevice NameCodeDateActions
510(k) K172264 OTW Takeru PTCA Balloon Dilatation CatheterLOX2018-03-19 View
510(k) K170941 RX NC Takeru PTCA Balloon Dilatation CatheterLOX2017-07-07 View
510(k) K163372 RX Takeru Balloon Dilatation CatheterLOX2017-04-07 View
510(k) K163479 R2P Metacross RXLIT2017-01-11 View
510(k) K160004 Crosstella OTWLIT2016-04-29 View
510(k) K160013 Crosperio OTWLIT2016-04-29 View
510(k) K152887 Crosperio RX PTA Balloon Dilatation CatheterLIT2016-01-22 View
510(k) K152873 Crosstella RX Balloon Dilatation CatheterLIT2016-01-22 View

Related Clinical Trials

NCT07687472Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous MalformationNOT_YET_RECRUITINGNCT05636124Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial AneurysmsACTIVE_NOT_RECRUITING
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