Cleared Traditional

K160242 - Reprocessed Livewire Steerable Diagnost...

K160242 is the FDA 510(k) clearance for Reprocessed Livewire Steerable Diagnost... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K160242 · Innovative Health, LLC · Cardiovascular device
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May 2016
Decision
99d
Days
Class 2
Risk

K160242 is an FDA 510(k) clearance for the Reprocessed Livewire Steerable Diagnostic EP 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 May 10, 2016 after a review of 99 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

Submission Details

510(k) Number K160242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date May 10, 2016
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K160242.
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · Innovative Health, LLC · Sep 2016
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
K153006 · Sterilmed, Inc. · Jun 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K160496 · Innovative Health, LLC · Jun 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
K160303 · Innovative Health, LLC · May 2016
Reprocessed Electrophysiology Catheter
K153153 · Innovative Health, LLC · Mar 2016
Reprocessed Electrophysiology Diagnostic Catheters
K150357 · Sterilmed, Inc. · Aug 2015