Cleared Traditional

K983456 - ENSITE 3000 SYSTEM

K983456 is an FDA 510(k) clearance for ENSITE 3000 SYSTEM, manufactured by Endocardial Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K983456 · Endocardial Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
203d
Days
Class 2
Risk

K983456 is an FDA 510(k) clearance for the ENSITE 3000 SYSTEM. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Endocardial Solutions, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 21, 1999 after a review of 203 days - an extended review cycle.

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 Endocardial Solutions, Inc. devices

FDA 510(k) Submission Details - K983456

510(k) Number K983456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 30, 1998
Decision Date April 21, 1999
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MTD Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K983456.
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
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,
K982540 · Cardiac Pathways Corp. · Jan 1999