Cleared Special

K993729 - MODIFICATION TO CARTO EP NAVIGATION SYSTEM

K993729 is an FDA 510(k) clearance for MODIFICATION TO CARTO EP NAVIGATION SYSTEM, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 29-day FDA review.

K993729 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Dec 1999
Decision
29d
Days
Class 2
Risk

K993729 is an FDA 510(k) clearance for the MODIFICATION TO CARTO EP 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 December 3, 1999 after a review of 29 days - a notably fast clearance cycle.

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. 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 Biosense Webster, Inc. devices

FDA 510(k) Submission Details - K993729

510(k) Number K993729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date December 03, 1999
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

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 359
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K993729.
EP MEDSYSTEMS, EP-WORKMATE
K994011 · Ep Medsystems, Inc. · Mar 2000
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QMS MAPPING SYSTEM,MODEL 2000
K990058 · Cathdata, Inc. · Dec 1999
ENSITE 3000 SYSTEM
K992479 · Endocardial Solutions, Inc. · Dec 1999
MAC-LAB SYSTEM
K992948 · General Electric Medical Systems Information Techn · Nov 1999
SYNEFLASH & SYNEVIEW
K990727 · Ela Medical, Inc. · Nov 1999