Cleared Traditional

K211662 - Reprocessed IntellaMap Orion High Resol...

K211662 is an FDA 510(k) clearance for Reprocessed IntellaMap Orion High Resol..., manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code NLG cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K211662 · Innovative Health, LLC · Cardiovascular device
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Nov 2021
Decision
170d
Days
Class 2
Risk

K211662 is an FDA 510(k) clearance for the Reprocessed IntellaMap Orion High Resolution Mapping Catheter. Classified as Catheter, Intracardiac Mapping, High-density, Reprocessed (product code NLG), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on November 18, 2021 after a review of 170 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 - K211662

510(k) Number K211662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date November 18, 2021
Days to Decision 170 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
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLG Device Classification - Class 2, Special Controls

Product Code NLG Catheter, Intracardiac Mapping, High-density, 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.