Cleared Traditional

ENSITE 3000 SYSTEM (K983456) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 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