Halo XP Diagnostic Electrophysiology Catheter, Reprocessed
510(k) K171788
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171788 | Date3 Nov 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Reprocessed Halo XP Diagnostic Electrophysiology Catheter
- 510(k) Number
- FDA Product Code
- NLH
- FDA applicant
- Innovative Health, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Halo XP Diagnostic Electrophysiology Catheter is a reprocessed electrode catheter designed for electrophysiological mapping and recording of cardiac structures. Its halo-shaped tip section, featuring ten pairs of platinum electrodes, facilitates precise stimulation and recording, particularly suited for mapping the tricuspid annulus. The high-torque shaft ensures navigational stability during fluoroscopic visualization.
This catheter is supplied as a reprocessed single-use device and is intended for use in electrophysiology laboratories. It is classified under FDA regulation number 870.1220 and holds a Traditional 510(k) clearance (K171788) from the FDA’s Cardiovascular Advisory Committee. Sterility and reprocessing details are not specified but must comply with applicable reprocessing standards to ensure safety and functionality.
Other devices from Innovative Health, LLC.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Reprocessed Halo XP Diagnostic Electrophysiology Catheter, and how does its design support this use?
The Reprocessed Halo XP Diagnostic Electrophysiology Catheter is designed for electrophysiological mapping and recording of cardiac structures, with a focus on the tricuspid annulus. Its halo-shaped tip section, featuring ten pairs of platinum electrodes, enables precise stimulation and recording, which is critical for accurate mapping during electrophysiology procedures. The high-torque shaft also enhances navigational stability, ensuring reliable fluoroscopic visualization during use.
Is this catheter intended for single-use or can it be reused after reprocessing, and what does that mean for the clinical setting?
The Reprocessed Halo XP Diagnostic Electrophysiology Catheter is supplied as a reprocessed single-use device, meaning it is intended for one-time use per patient. However, it is specifically reprocessed for reuse in electrophysiology laboratories, provided it adheres to applicable reprocessing standards to maintain safety and functionality. Clinicians should follow established reprocessing protocols to ensure sterility and performance.
What regulatory pathway was followed for this catheter, and which advisory committee was involved in its clearance?
The Reprocessed Halo XP Diagnostic Electrophysiology Catheter received a Traditional 510(k) clearance (K171788) from the FDA’s Cardiovascular Advisory Committee. This clearance confirms that the device is substantially equivalent to a legally marketed predicate, ensuring it meets FDA standards for safety and effectiveness in electrophysiological mapping and recording.
Are there multiple sizes or models of this catheter, and how would a clinician determine which one to use?
The Reprocessed Halo XP Diagnostic Electrophysiology Catheter comes in multiple models, as indicated by the FEI numbers (e.g., 3011276773, 3003076831, etc.), which likely correspond to different catheter lengths, diameters, or shaft flexibilities. Clinicians should consult the reprocessed device’s labeling or manufacturer documentation to select the appropriate model based on patient anatomy, procedural requirements, and the specific cardiac structures being mapped.
How should this catheter be stored, and are there any special considerations for its handling in the electrophysiology lab?
While specific storage instructions are not detailed in the data, reprocessed single-use catheters like this one should be stored in a clean, dry environment, protected from contamination and physical damage. The electrophysiology lab should follow manufacturer guidelines for handling and storage to maintain sterility and functionality, ensuring it remains ready for use in mapping procedures without compromising performance.