# Trireme Medical, Inc.

- Location (FDA's records): Pleasonton, CA
- FDA decisions: 15 (2010–2022): 14 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Trireme Medical, Inc. (12); Trireme Medical, LLC (3)
- Product codes: LOX (5), LIT (5), DQY (4), ONU (1)
- Predicates its devices cite: 52 (31 its own); citations of its devices by later devices: 34 (31 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ev3, Inc.: 8 (https://510kreport.com/company/ev3)
- Ymed, Inc.: 5 (https://510kreport.com/company/ymed)
- Scimed Life Systems, Inc.: 2 (https://510kreport.com/company/scimed-life-systems)
- Creganna-Tactx Medical: 2 (https://510kreport.com/company/creganna-tactx-medical)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- NuMED, Inc.: 1 (https://510kreport.com/company/numed)

## Firms that cite its devices most
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Intuit Medical, LLC: 1 (https://510kreport.com/company/intuit-medical)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Its most-cited devices
- K101062: Glider Pta Balloon Catheter (2010), cited by 6
- K111738: Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018) (2011), cited by 4
- K111544: Glider Ptca Balloon Catheter (2012), cited by 4
- K103534: Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire (2011), cited by 4
- K112281: Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX (2011), cited by 2
- K121681: Glider Ptca Balloon Catheter (2012), cited by 2

## Recent decisions
- P210039: Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) (Nov 4, 2022)
- K153682: Chocolate XD PTCA Balloon Catheter (Jun 23, 2016)
- K150292: Chocolate PTCA Balloon Catheter (Apr 9, 2015)
- K133633: Chocolate Ptca Bolloon Catheter (Jun 2, 2014)
- K130414: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.018 (Jun 15, 2013)
- K122070: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.18 G (Aug 15, 2012)
- K121681: Glider Ptca Balloon Catheter (Jun 26, 2012)
- K121402: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the Wire) 0.018' G (Jun 8, 2012)

Source page: https://510kreport.com/company/trireme-medical