FDA 510(k) Applications Submitted by Shiva Ardakani
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150292 |
02/06/2015 |
Chocolate PTCA Balloon Catheter |
TRIREME MEDICAL, LLC |
| 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. |
| K120677 |
03/06/2012 |
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) |
TRIREME MEDICAL INC |
| K101062 |
04/16/2010 |
GLIDER PTA BALLOON CATHETER |
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. |
| K111544 |
06/03/2011 |
GLIDER PTCA BALLOON CATHETER |
TRIREME MEDICAL INC |
| K121681 |
06/07/2012 |
GLIDER PTCA BALLOON CATHETER |
TRIREME MEDICAL, INC. |
| K122070 |
07/16/2012 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G |
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. |
| K133633 |
11/26/2013 |
CHOCOLATE PTCA BOLLOON CATHETER |
TRIREME MEDICAL INC |
| K103534 |
12/01/2010 |
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE |
TRIREME MEDICAL, INC. |
| K153682 |
12/22/2015 |
Chocolate XD PTCA Balloon Catheter |
TriReme Medical, LLC |
|
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