Cleared Special

K000332 - NOGA CARDIAC NAVIGATION SYSTEM

K000332 is the FDA 510(k) clearance for NOGA CARDIAC NAVIGATION SYSTEM by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Special 510(k) pathway after a 91-day FDA review.

K000332 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
91d
Days
Class 2
Risk

K000332 is an FDA 510(k) clearance for the NOGA CARDIAC NAVIGATION SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on May 4, 2000 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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.

View all Biosense Webster, Inc. devices

Submission Details

510(k) Number K000332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2000
Decision Date May 04, 2000
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 246
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K000332.
CATHCOR DESKTOP
K002137 · Siemens Elema AB · Oct 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · Biosense Webster, Inc. · May 2000
CARTO EP NAVIGATION SYSTEM
K000248 · Biosense Webster, Inc. · May 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · Biosense Webster, Inc. · Dec 1999
SYNEFLASH & SYNEVIEW
K990727 · Ela Medical, Inc. · Nov 1999
CARTO EP NAVIGATION SYSTEM
K992968 · Biosense Webster, Inc. · Sep 1999