Company ยท US
Trireme Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2016. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 23, 2016 | K153682 | Chocolate XD PTCA Balloon Catheter Trireme Medical, LLC | LOX |
| Apr 9, 2015 | K150292 | Chocolate PTCA Balloon Catheter Trireme Medical, LLC | LOX |
| Jun 2, 2014 | K133633 | CHOCOLATE PTCA BOLLOON CATHETER Trireme Medical, Inc. | LOX |
| Jun 15, 2013 | K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 Trireme Medical, Inc. | LIT |
| Aug 15, 2012 | K122070 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G Trireme Medical, Inc. | LIT |
| Jun 26, 2012 | K121681 | GLIDER PTCA BALLOON CATHETER Trireme Medical, Inc. | LOX |
| Jun 8, 2012 | K121402 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G Trireme Medical, Inc. | LIT |
| Mar 15, 2012 | K120677 | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) Trireme Medical, Inc. | LIT |
| Mar 2, 2012 | K111544 | GLIDER PTCA BALLOON CATHETER Trireme Medical, Inc. | LOX |
| Dec 14, 2011 | K111738 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) Trireme Medical, Inc. | DQY |
| Aug 17, 2011 | K112281 | GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX Trireme Medical, Inc. | DQY |
| Jan 5, 2011 | K103534 | GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE Trireme Medical, Inc. | DQY |
| May 12, 2010 | K101062 | GLIDER PTA BALLOON CATHETER Trireme Medical, Inc. | LIT |
| Feb 12, 2010 | K094019 | GLIDER PTA BALLOON CATHETER Trireme Medical, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||