Cleared Traditional

K161393 - Reprocessed Orbiter ST Steerable Diagnostic EP Catheter

K161393 is an FDA 510(k) clearance for Reprocessed Orbiter ST Steerable Diagno..., 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 160-day FDA review.

K161393 · Innovative Health, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
160d
Days
Class 2
Risk

K161393 is an FDA 510(k) clearance for the Reprocessed Orbiter ST 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 October 26, 2016 after a review of 160 days - an extended review cycle.

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 - K161393

510(k) Number K161393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2016
Decision Date October 26, 2016
Days to Decision 160 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
35d slower than avg
Panel avg: 125d · This submission: 160d
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 K161393.
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · Innovative Health, LLC · Dec 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · Innovative Health, LLC · Dec 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
K160421 · Innovative Health, LLC · Nov 2016
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