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FDA 510(k) Applications Submitted by TRIREME MEDICAL, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K111738
06/21/2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
TRIREME MEDICAL, INC.
K130414
02/19/2013
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
TRIREME MEDICAL, INC.
K121402
05/10/2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G
TRIREME MEDICAL, INC.
K121681
06/07/2012
GLIDER PTCA BALLOON CATHETER
TRIREME MEDICAL, INC.
K112281
08/09/2011
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
TRIREME MEDICAL, INC.
K103534
12/01/2010
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
TRIREME MEDICAL, INC.
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