Medical Device Manufacturer · US , Washington, Dc , DC

Barrx Medical, Incorporated - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2005

Recent clearances: HALO 360 & SIZING BALLOON, MODEL 3441C, HALO ABLATION CATHETER, MODEL 90-9100, HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A

View 13 510(k) Devices ↓

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Barrx Medical, Incorporated General & Plastic Surgery ✕

13 devices

1-12 of 13

Cleared Jan 15, 2010

HALO 360 & SIZING BALLOON, MODEL 3441C

General & Plastic Surgery · 30d

Cleared Jan 08, 2010

HALO ABLATION CATHETER, MODEL 90-9100

General & Plastic Surgery · 102d

Cleared Nov 10, 2009

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A

General & Plastic Surgery · 89d

Cleared Feb 10, 2009

HALO ABLATION CATHETER

General & Plastic Surgery · 56d

Cleared Feb 02, 2009

MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20,...

General & Plastic Surgery · 49d

Cleared Oct 08, 2008

HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B

General & Plastic Surgery · 64d

Cleared Apr 02, 2008

BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS

General & Plastic Surgery · 34d

Cleared Jun 29, 2007

HALO360' COAGULATION CATHETER

General & Plastic Surgery · 24d

Cleared Nov 14, 2006

BARRX HALO COAGULATION SYSTEM

General & Plastic Surgery · 85d

Cleared Nov 09, 2006

HALO90 COAGULATION CATHETER

General & Plastic Surgery · 58d

Cleared Aug 28, 2006

HALO COAGULATION CATHETER

General & Plastic Surgery · 26d

Cleared Apr 21, 2006

BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX...

General & Plastic Surgery · 88d