Trireme Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Trireme Medical, Inc.” (first 2010, latest 2016), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 40 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 29 |
| 2013 | 1 | 116 |
| 2014 | 1 | 188 |
| 2015 | 1 | 62 |
| 2016 | 1 | 184 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 5 | 5 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 5 | 5 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | 1 | 0 |
Review panels
- Cardiovascular (15)
Most recent Trireme Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153682 | Chocolate XD PTCA Balloon Catheter | LOX | 2016-06-23 | 184 |
| K150292 | Chocolate PTCA Balloon Catheter | LOX | 2015-04-09 | 62 |
| K133633 | CHOCOLATE PTCA BOLLOON CATHETER | LOX | 2014-06-02 | 188 |
| K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 | LIT | 2013-06-15 | 116 |
| K122070 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G | LIT | 2012-08-15 | 30 |
| K121681 | GLIDER PTCA BALLOON CATHETER | LOX | 2012-06-26 | 19 |
| K121402 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G | LIT | 2012-06-08 | 29 |
| K120677 | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) | LIT | 2012-03-15 | 9 |
| K111544 | GLIDER PTCA BALLOON CATHETER | LOX | 2012-03-02 | 273 |
| K111738 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) | DQY | 2011-12-14 | 176 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210039 | PMA | Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) | 2022-11-04 |
Recalls
openFDA lists no recalls under a recalling firm named Trireme Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Trireme Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT02924857: The Chocolate Touch Study (Active not recruiting, started 2017-07-26)
- NCT02396186: An Assessment of the Glider Balloon in Complex Lesions (Completed, started 2015-03)
- NCT02129127: Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial (Completed, started 2014-03)
- NCT01184352: Glider PTCA Balloon Catheter Registry (Completed, started 2010-07)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Trireme Medical, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trireme Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Trireme Medical, Inc.” (first 2010, latest 2016), plus 1 PMA decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trireme Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trireme Medical, Inc. is 40 days.
Which FDA product codes appear under Trireme Medical, Inc.?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 5); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 5); DQY (Catheter, Percutaneous, 4).
Next steps
- See all 14 Trireme Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Trireme Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.