Cleared Traditional

K133916 - CARTO 3 EP NAVIGATION SYSTEM

K133916 is the FDA 510(k) clearance for CARTO 3 EP NAVIGATION SYSTEM by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K133916 · Biosense Webster, Inc. · Cardiovascular device
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Jul 2014
Decision
190d
Days
Class 2
Risk

K133916 is an FDA 510(k) clearance for the CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2. 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 July 1, 2014 after a review of 190 days - an extended review cycle.

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

Submission Details

510(k) Number K133916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date July 01, 2014
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 229
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