Cleared Traditional

K091789 - CARTO RMT EP NAVIGATION SYSTEM V8

K091789 is an FDA 510(k) clearance for CARTO RMT EP NAVIGATION SYSTEM V8, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K091789 · Biosense Webster, Inc. · Cardiovascular device
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Oct 2009
Decision
106d
Days
Class 2
Risk

K091789 is an FDA 510(k) clearance for the CARTO RMT EP NAVIGATION SYSTEM V8. 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 October 1, 2009 after a review of 106 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosense Webster, Inc. devices

FDA 510(k) Submission Details - K091789

510(k) Number K091789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date October 01, 2009
Days to Decision 106 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 348
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K091789.
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
K090017 · Biosense Webster, Inc. · Oct 2009
RADIANALYZER XPRESS
K092105 · Radi Medical Systems AB · Oct 2009
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · St Jude Medical · Oct 2009
HORIZON XVU
K091165 · Mennen Medical , Ltd. · Aug 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · iRhythm Technologies, Inc. · Jul 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · St Jude Medical · May 2009