Cleared Special

K011734 - 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX

K011734 is an FDA 510(k) clearance for 6-FRENCH, manufactured by Mogul Enterprises. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 28-day FDA review.

K011734 · Mogul Enterprises · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
28d
Days
Class 2
Risk

K011734 is an FDA 510(k) clearance for the 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX,.... Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Mogul Enterprises (San Jose, US). The FDA issued a Cleared decision on July 3, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Mogul Enterprises devices

FDA 510(k) Submission Details - K011734

510(k) Number K011734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2001
Decision Date July 03, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 134
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K011734.
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161 · Biosense Webster, Inc. · Jul 2003
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380 · St Jude Medical · Oct 2002
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
K013484 · Stereotaxis, Inc. · May 2002
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · St Jude Medical · Jul 2001
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
K002976 · St Jude Medical · Dec 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · Biosense Webster, Inc. · Aug 2000