Cleared Traditional

K012089 - CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM

K012089 is an FDA 510(k) clearance for CATHEFFECTS' DESAI VECTORCATH MAPPING S..., manufactured by Catheffects, LLC. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K012089 · Catheffects, LLC · Cardiovascular device
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Jan 2002
Decision
207d
Days
Class 2
Risk

K012089 is an FDA 510(k) clearance for the CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Catheffects, LLC (Roseville, US). The FDA issued a Cleared decision on January 28, 2002 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Catheffects, LLC devices

FDA 510(k) Submission Details - K012089

510(k) Number K012089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2001
Decision Date January 28, 2002
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 351
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K012089.
QUINTON Q-CATH, MODEL 000460
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MAC-LAB/CARDIOLAB EP/COMBOLAB
K021366 · General Electric Medical Systems Information Techn · Jul 2002
PHYSIOLOG, SERIES 95000
K013032 · Camtronics, Ltd. · Jun 2002
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · General Electric Medical Systems Information Techn · Jan 2002
CARTO XP EP NAVIGATION SYSTEM
K013083 · Biosense Webster, Inc. · Nov 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
K012206 · Cambridge Heart, Inc. · Oct 2001