Cleared Traditional

K180710 - Reprocessed DecaNav Diagnostic Electrop...

K180710 is the FDA 510(k) clearance for Reprocessed DecaNav Diagnostic Electrop... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K180710 · Innovative Health, LLC · Cardiovascular device
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Jun 2018
Decision
92d
Days
Class 2
Risk

K180710 is an FDA 510(k) clearance for the Reprocessed DecaNav 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 June 19, 2018 after a review of 92 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 K180710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date June 19, 2018
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 K180710.
Reprocessed Marinr Diagnostic EP Catheter
K181897 · Innovative Health, LLC · Nov 2018
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 Halo XP Diagnostic Electrophysiology Catheter
K171788 · Innovative Health, LLC · Nov 2017
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