KANEKA Corporation - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
KANEKA Corporation has 10 FDA 510(k) cleared cardiovascular devices. Based in Tokyo, JP.
Historical record: 10 cleared submissions from 2015 to 2018.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - KANEKA Corporation
10 devices
Cleared
Mar 19, 2018
OTW Takeru PTCA Balloon Dilatation Catheter
Cardiovascular
235d
Cleared
Jul 07, 2017
RX NC Takeru PTCA Balloon Dilatation Catheter
Cardiovascular
99d
Cleared
Apr 07, 2017
RX Takeru Balloon Dilatation Catheter
Cardiovascular
127d
Cleared
Jan 11, 2017
R2P Metacross RX
Cardiovascular
30d
Cleared
Apr 29, 2016
Crosstella OTW
Cardiovascular
116d
Cleared
Apr 29, 2016
Crosperio OTW
Cardiovascular
116d
Cleared
Jan 22, 2016
Crosstella RX Balloon Dilatation Catheter
Cardiovascular
114d
Cleared
Jan 22, 2016
Crosperio RX PTA Balloon Dilatation Catheter
Cardiovascular
114d
Cleared
Sep 24, 2015
Metacross OTW PTA Balloon Dilatation Catheter
Cardiovascular
59d
Cleared
Aug 03, 2015
Metacross RX PTA Balloon Dilitation Catheter
Cardiovascular
124d