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.

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
Combination Product No
PCCP Authorized No
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 182
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K011734.
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520 · Cardiac Assist Devices, Inc. · Mar 2002
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
K011361 · Catheffects, LLC · Sep 2001
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · Zynergy Cardio Vasular (Zcv), Inc. · Jul 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · St Jude Medical · Jul 2001
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
K010471 · Irvine Biomedical, Inc. · Jun 2001
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
K002976 · St Jude Medical · Dec 2000
K011734 · 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
Download PDF Mogul Enterprises