# Barrx Medical, Incorporated

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 16 (2005–2012): 16 510(k) clearances
- Names in FDA's records: Barrx Medical, Incorporated (13); Barrx Medical, Inc. (3)
- Product codes: GEI (16)
- Predicates its devices cite: 43 (33 its own); citations of its devices by later devices: 46 (33 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stellartech Research Corp.: 7 (https://510kreport.com/company/stellartech-research)
- Radiotherapeutics Corp.: 1 (https://510kreport.com/company/radiotherapeutics)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)

## Firms that cite its devices most
- Covidien: 6 (https://510kreport.com/company/covidien)
- Covidien Iic: 3 (https://510kreport.com/company/covidien-iic)
- C2 Therapeutics, Inc.: 2 (https://510kreport.com/company/c2-therapeutics)
- Aqua Medical, Inc.: 2 (https://510kreport.com/company/aqua-medical)

## Its most-cited devices
- K051168: Barrx Halo 360 System, Model 1100C-115A (2005), cited by 9
- K060169: Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F (2006), cited by 6
- K062723: HALO90 Coagulation Catheter (2006), cited by 5
- K093008: Halo Ablation Catheter, Model 90-9100 (2010), cited by 5
- K083737: Halo Ablation Catheter (2009), cited by 4
- K112454: HALO60 Ablation Catheter (2012), cited by 3

## Recent decisions
- K120431: HALO90 Ultra Ablation Catheter (May 3, 2012)
- K112454: HALO60 Ablation Catheter (Jan 5, 2012)
- K101111: Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200 (Jun 18, 2010)
- K093855: Halo 360 & Sizing Balloon, Model 3441C (Jan 15, 2010)
- K093008: Halo Ablation Catheter, Model 90-9100 (Jan 8, 2010)
- K092487: Haloflex Energy Generator, Models 1190A-115A and 1190A-230A (Nov 10, 2009)
- K083737: Halo Ablation Catheter (Feb 10, 2009)
- K083711: Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 (Feb 2, 2009)

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