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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