Trireme Medical, Inc.
Pleasanton, CA, US
Trireme Medical, Inc. appears in FDA device records in Pleasanton, CA. FDA records list 14 510(k) clearances between and , 2 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 2
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Trireme Medical, Inc. between 2010 and 2016. The busiest year on record is 2012, with 5. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153682 | Chocolate XD PTCA Balloon Catheter | LOX | Substantially Equivalent | |
| K150292 | Chocolate PTCA Balloon Catheter | LOX | Substantially Equivalent | |
| K133633 | CHOCOLATE PTCA BOLLOON CATHETER | LOX | Substantially Equivalent | |
| K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 | LIT | Substantially Equivalent | |
| K122070 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G | LIT | Substantially Equivalent | |
| K121681 | GLIDER PTCA BALLOON CATHETER | LOX | Substantially Equivalent | |
| K121402 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G | LIT | Substantially Equivalent | |
| K120677 | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) | LIT | Substantially Equivalent | |
| K111544 | GLIDER PTCA BALLOON CATHETER | LOX | Substantially Equivalent | |
| K111738 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) | DQY | Substantially Equivalent | |
| K112281 | GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX | DQY | Substantially Equivalent | |
| K103534 | GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE | DQY | Substantially Equivalent | |
| K101062 | GLIDER PTA BALLOON CATHETER | LIT | Substantially Equivalent | |
| K094019 | GLIDER PTA BALLOON CATHETER | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain