Cleared Traditional

K011361 - DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE

K011361 is an FDA 510(k) clearance for DESAI VECTORCATH MAPPING CATHETER, manufactured by Catheffects, LLC. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K011361 · Catheffects, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
126d
Days
Class 2
Risk

K011361 is an FDA 510(k) clearance for the DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Catheffects, LLC (Roseville, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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.

FDA 510(k) Submission Details - K011361

510(k) Number K011361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2001
Decision Date September 06, 2001
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 185
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K011361.
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
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520 · Cardiac Assist Devices, Inc. · Mar 2002
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · Zynergy Cardio Vasular (Zcv), Inc. · Jul 2001
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
K011734 · Mogul Enterprises · Jul 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · St Jude Medical · Jul 2001
K011361 · DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
Download PDF FDA Summary Catheffects, LLC