Cleared Special

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER (K121006) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121006 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
30d
Days
Class 2
Risk

K121006 is an FDA 510(k) clearance for the ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St Jude Medical devices

Submission Details

510(k) Number K121006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2012
Decision Date May 03, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K121006.
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · Biosense Webster, Inc. · Jul 2020
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · St. Jude Medical, Inc. · Apr 2018
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · Boston Scientific Corp · May 2002
CONSTELLATION CATHETER, MODEL 8031
K003782 · Boston Scientific Corp · Feb 2001
CONSTELLATION CATHETERS
K000277 · Boston Scientific Corp · Sep 2000