Cleared Special

K000277 - CONSTELLATION CATHETERS

K000277 is an FDA 510(k) clearance for CONSTELLATION CATHETERS, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Special 510(k) pathway after a 239-day FDA review.

K000277 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
239d
Days
Class 2
Risk

K000277 is an FDA 510(k) clearance for the CONSTELLATION CATHETERS. 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 September 26, 2000 after a review of 239 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. 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. Standard predicate reliance. 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 - K000277

510(k) Number K000277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2000
Decision Date September 26, 2000
Days to Decision 239 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
114d slower than avg
Panel avg: 125d · This submission: 239d
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 K000277.
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · Boston Scientific Corp · May 2002
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K012926 · Endocardial Solutions, Inc. · Sep 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · Boston Scientific Corp · Feb 2001
CONSTELLATION CATHETERS, MODEL 8039
K992777 · Boston Scientific Corp · Nov 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER
K990795 · Cardiac Pathways Corp. · Jun 1999
ENSITE 3000 SYSTEM
K983456 · Endocardial Solutions, Inc. · Apr 1999
K000277 · CONSTELLATION CATHETERS
Download PDF FDA Summary Boston Scientific Corp