Cleared Traditional

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K223026) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223026 · Northeast Scientific, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2023
Decision
127d
Days
Class 2
Risk

K223026 is an FDA 510(k) clearance for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on February 3, 2023 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Northeast Scientific, Inc. devices

Submission Details

510(k) Number K223026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date February 03, 2023
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OWQ Reprocessed Intravascular Ultrasound Catheter

All 18
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K223026.
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · Abbott Medical · Jun 2023
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
K230584 · Vein 360, LLC · Jun 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · Abbott Medical · May 2023
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · Abbott Medical · Dec 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · Innovative Health, LLC · May 2022
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · Innovative Health, LLC · Nov 2020