Cleared Special

K021232 - CONSTELLATION CATHETERS

K021232 is the FDA 510(k) clearance for CONSTELLATION CATHETERS by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code MTD) cleared through the Special 510(k) pathway after a 28-day FDA review.

K021232 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
28d
Days
Class 2
Risk

K021232 is an FDA 510(k) clearance for the CONSTELLATION CATHETERS, MODEL 8031M. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 28 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 Boston Scientific Corp devices

Submission Details

510(k) Number K021232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 18, 2002
Decision Date May 16, 2002
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 24
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K021232.
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · Biosense Webster, Inc. · May 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · St Jude Medical · 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 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