Cleared Traditional

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) - FDA 510(k) Clearance

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

K200812 · Philips Image Guided Therapy Corporation · Cardiovascular device
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Sep 2020
Decision
159d
Days
Class 2
Risk

K200812 is an FDA 510(k) clearance for the VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Cat.... Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Philips Image Guided Therapy Corporation (San Diego, US). The FDA issued a Cleared decision on September 2, 2020 after a review of 159 days - an extended review cycle.

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 Philips Image Guided Therapy Corporation devices

Submission Details

510(k) Number K200812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2020
Decision Date September 02, 2020
Days to Decision 159 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
34d slower than avg
Panel avg: 125d · This submission: 159d
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 Consultant

Philips Ultrasound, Inc.
Rand Daoud

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K200812.
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K212959 · Siemens Medical Solutions USA, Inc. · Oct 2021
NuVision ICE Catheter
K201775 · Nuvera Medical, Inc. · Mar 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K203726 · Siemens Medical Solutions USA, Inc. · Jan 2021
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
K200195 · Northeast Scientific, Inc. · Jun 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