Asahi Intecc Co., Ltd. - FDA 510(k) Cleared Devices
83
Total
83
Cleared
0
Denied
67 devices
Cleared
Aug 25, 2016
ASAHI Corsair Pro
Cardiovascular
126d
Cleared
Jun 21, 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
Cardiovascular
238d
Cleared
Jun 14, 2016
ASAHI Corsair Armet
Cardiovascular
29d
Cleared
Mar 04, 2016
ASAHI Corsair Armet
Cardiovascular
207d
Cleared
Feb 25, 2016
ASAHI Astato XS 40
Cardiovascular
90d
Cleared
Jan 22, 2016
ASAHI Caravel
Cardiovascular
148d
Cleared
Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
Cardiovascular
130d
Cleared
Jun 23, 2015
ASAHI Corsair Microcatheter
Cardiovascular
60d
Cleared
Mar 09, 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
Cardiovascular
231d
Cleared
Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
Cardiovascular
155d
Cleared
Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
Cardiovascular
89d
Cleared
Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
Cardiovascular
71d
Cleared
Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION...
Cardiovascular
207d
Cleared
Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
Cardiovascular
207d
Cleared
Feb 06, 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
Cardiovascular
49d
Cleared
Sep 09, 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
Cardiovascular
422d
Cleared
Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
Cardiovascular
236d
Cleared
Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
Cardiovascular
35d
Cleared
Sep 22, 2010
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
Cardiovascular
205d
Cleared
Feb 26, 2010
ASAHI ZENYTEEX GUIDING CATHETER
Cardiovascular
309d
Cleared
Feb 03, 2009
ASAHI CORSAIR MICROCATHETER
Cardiovascular
105d
Cleared
Jan 29, 2009
ASAHI SUOH PTCA GUIDE WIRE
Cardiovascular
31d
Cleared
Jan 12, 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
Cardiovascular
81d
Cleared
Nov 21, 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
Cardiovascular
29d
Cleared
Jan 09, 2008
ASAHI PTCA GUIDE WIRE
Cardiovascular
280d