Cleared Traditional

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (K200195) - FDA 510(k) Clearance

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

K200195 · Northeast Scientific, Inc. · Cardiovascular device
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Jun 2020
Decision
147d
Days
Class 2
Risk

K200195 is an FDA 510(k) clearance for the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on June 22, 2020 after a review of 147 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 K200195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2020
Decision Date June 22, 2020
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
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 - OBJ Catheter, Ultrasound, Intravascular

All 42
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K200195.
NuVision ICE Catheter
K201775 · Nuvera Medical, Inc. · Mar 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K203726 · Siemens Medical Solutions USA, Inc. · Jan 2021
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
K200812 · Philips Image Guided Therapy Corporation · Sep 2020
Reconnaissance PV .018 OTW Digital IVUS Catheter
K200410 · Philips Image Guided Therapy Corporation · May 2020
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
K193183 · Acist Medical Systems, Inc. · Mar 2020
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K191175 · Acist Medical Systems, Inc. · Jun 2019