Trireme Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CHOCOLATE PTCA BOLLOON CATHETER, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Trireme Medical, Inc. Cardiovascular ✕
12 devices
Cleared
Jun 02, 2014
CHOCOLATE PTCA BOLLOON CATHETER
Cardiovascular
188d
Cleared
Jun 15, 2013
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
Cardiovascular
116d
Cleared
Aug 15, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
Cardiovascular
30d
Cleared
Jun 26, 2012
GLIDER PTCA BALLOON CATHETER
Cardiovascular
19d
Cleared
Jun 08, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA...
Cardiovascular
29d
Cleared
Mar 15, 2012
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
Cardiovascular
9d
Cleared
Mar 02, 2012
GLIDER PTCA BALLOON CATHETER
Cardiovascular
273d
Cleared
Dec 14, 2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
Cardiovascular
176d
Cleared
Aug 17, 2011
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX,...
Cardiovascular
8d
Cleared
Jan 05, 2011
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
Cardiovascular
35d
Cleared
May 12, 2010
GLIDER PTA BALLOON CATHETER
Cardiovascular
26d
Cleared
Feb 12, 2010
GLIDER PTA BALLOON CATHETER
Cardiovascular
45d