Cleared Traditional

K171788 - Reprocessed Halo XP Diagnostic Electrophysiology Catheter

K171788 is an FDA 510(k) clearance for Reprocessed Halo XP Diagnostic Electrop..., manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code NLH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K171788 · Innovative Health, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
141d
Days
Class 2
Risk

K171788 is an FDA 510(k) clearance for the Reprocessed Halo XP Diagnostic Electrophysiology Catheter. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on November 3, 2017 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Health, LLC devices

FDA 510(k) Submission Details - K171788

510(k) Number K171788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2017
Decision Date November 03, 2017
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLH Device Classification - Class 2, Special Controls

Product Code NLH Catheter, Recording, Electrode, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - NLH Catheter, Recording, Electrode, Reprocessed

All 68
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K171788.
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · Innovative Health, LLC · Oct 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · Innovative Health, LLC · Oct 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · Innovative Health, LLC · Jun 2018
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · Innovative Health, LLC · Oct 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
K170922 · Innovative Health, LLC · Jun 2017
Supreme and Response Electrophysiology Catheters
K161272 · Surgical Instrument Service and Savings, Inc. · May 2017