FDA 510(k) Applications Submitted by Kaneka Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K160004 01/04/2016 Crosstella OTW KANEKA CORPORATION
K160013 01/04/2016 Crosperio OTW KANEKA CORPORATION
K170941 03/30/2017 RX NC Takeru PTCA Balloon Dilatation Catheter Kaneka Corporation
K150865 04/01/2015 Metacross RX PTA Balloon Dilitation Catheter Kaneka Corporation
K152080 07/27/2015 Metacross OTW PTA Balloon Dilatation Catheter Kaneka Corporation
K172264 07/27/2017 OTW Takeru PTCA Balloon Dilatation Catheter Kaneka Corporation
K152873 09/30/2015 Crosstella RX Balloon Dilatation Catheter KANEKA CORPORATION
K152887 09/30/2015 Crosperio RX PTA Balloon Dilatation Catheter Kaneka Corporation
K163372 12/01/2016 RX Takeru Balloon Dilatation Catheter KANEKA CORPORATION
K163479 12/12/2016 R2P Metacross RX KANEKA CORPORATION


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