Cleared Special

K121006 - ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER

K121006 is an FDA 510(k) clearance for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC..., manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Special 510(k) pathway after a 30-day FDA review.

K121006 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K121006

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K121006.
FIRMAP CATHETER
K130827 · Topera, Inc. · Oct 2013
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · Biosense Webster, Inc. · Mar 2013
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · Biosense Webster, Inc. · May 2012
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
K050217 · Biosense Webster, Inc. · Mar 2005
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · Boston Scientific Corp · May 2002
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K012926 · Endocardial Solutions, Inc. · Sep 2001
K121006 · ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
Download PDF FDA Summary St Jude Medical