Cleared Traditional

CARTO 3 EP Navigation System, Version 6.0 and Accessories

K170600 · Biosense Webster, Inc. · Cardiovascular
Jul 2017
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K170600 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 6.0 and Accessories, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 25, 2017, 146 days after receiving the submission on March 1, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K170600 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2017
Decision Date July 25, 2017
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

Similar Devices — DQK Computer, Diagnostic, Programmable

All 423
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO? 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
K254089 · Centerline Biomedical, Inc. · Feb 2026
Holter ECG and ABP system (HolterABP)
K251591 · Edan Instruments, Inc. · Feb 2026
SafeBeat Rx App
K251218 · Safebeat Rx, Inc. · Feb 2026
NorthStar? Mapping System
K252164 · Imricor Medical Systems · Jan 2026