MODIFICATION TO: HALO COAGULATION CATHETER - 32041-18

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K083711 ↗

FDA Product Code

GEI

Models / Variants

32041-18

32041-20

32041-22

32041-25

32041-28

32041-31

32041-34

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Barrx Models HALO360 and HALO360+ Coagulation Catheters

  Class II

  FDA 510(k) K080557 Active Cleared 2 Apr 2008

• Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F

  Class II

  FDA 510(k) K060169 Active Cleared 21 Apr 2006

• Halo Ablation Catheter, Model 90-9100

  Class II

  FDA 510(k) K093008 Active Cleared 8 Jan 2010

• HALO360 Energy Generator, Models 1100C-115B and 1100C-230B

  Class II

  FDA 510(k) K082202 Active Cleared 8 Oct 2008

• HALO90 Coagulation Catheter

  Class II

  FDA 510(k) K062723 Active Cleared 9 Nov 2006

• Haloflex Energy Generator, Models 1190A-115A and 1190A-230A

  Class II

  FDA 510(k) K092487 Active Cleared 10 Nov 2009

See all devices from Barrx Medical, Incorporated →

• What is the Modification to Halo Coagulation Catheter used for?

  The device is a coagulation catheter intended for use in ablation procedures, based on the device type and intended use context provided in the submission data, with no changes to indications for use compared to the predicate device.

• How is the Modification to Halo Coagulation Catheter supplied?

  The device is supplied as a modification to an existing catheter system, with no changes in construction, materials, principle of operation, intended use, or indications for use compared to the predicate device.

• Is the Modification to Halo Coagulation Catheter sterile or single-use?

  The device data does not specify sterility or single-use status; however, as a modification to an existing catheter system with no changes in construction or materials, it retains the same supply characteristics as the predicate device, which would need to be consulted for those details.

• What models are included in the Modification to Halo Coagulation Catheter?

  The modification applies to Halo Coagulation Catheter models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, and 32041-34, as explicitly identified in the device name and specifications.

• What regulatory pathway was used for the Modification to Halo Coagulation Catheter?

  The device is authorized under FDA 510(k) clearance K083711, as stated in the device data, and was determined to be substantially equivalent to its predicate.