Cleared Traditional

MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER (K990795) - FDA 510(k) Clearance

Also marketed or referenced as:
CARDIAC PATHWAYS EGM ADAPTER CABLES

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

K990795 · Cardiac Pathways Corp. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 1999
Decision
90d
Days
Class 2
Risk

K990795 is an FDA 510(k) clearance for the MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Cardiac Pathways Corp. (Sunnyvale, US). The FDA issued a Cleared decision on June 8, 1999 after a review of 90 days - within the typical 510(k) review window.

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 Cardiac Pathways Corp. devices

Submission Details

510(k) Number K990795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date June 08, 1999
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - MTD Catheter, Intracardiac Mapping, High-density Array

All 21
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K990795.
CONSTELLATION CATHETER, MODEL 8031
K003782 · Boston Scientific Corp · Feb 2001
CONSTELLATION CATHETERS
K000277 · Boston Scientific Corp · Sep 2000
CONSTELLATION CATHETERS, MODEL 8039
K992777 · Boston Scientific Corp · Nov 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · Boston Scientific Corp · Mar 1999