Cleared Special

K191660 - CARTO 3 EP Navigation System, Version 7.1 and Accessories

K191660 is an FDA 510(k) clearance for CARTO 3 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.

K191660 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
29d
Days
Class 2
Risk

K191660 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 7.1 and Accessories. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 20, 2019 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.

FDA 510(k) Submission Details - K191660

510(k) Number K191660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2019
Decision Date July 20, 2019
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 437
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K191660.
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K191660 · CARTO 3 EP Navigation System, Version 7.1 and Accessories
Download PDF FDA Summary Biosense Webster, Inc.