Cleared Abbreviated

SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX (K993698) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K993698 · Mogul Enterprises · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
288d
Days
Class 2
Risk

K993698 is an FDA 510(k) clearance for the SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX. 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 August 16, 2000 after a review of 288 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mogul Enterprises devices

Submission Details

510(k) Number K993698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1999
Decision Date August 16, 2000
Days to Decision 288 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 125d · This submission: 288d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 50
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K993698.
BLAZER DX-20 DIAGNOSTIC CATHETER
K081576 · Boston Scientific Corp · Feb 2009
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
K033050 · Medtronic Vascular · Mar 2004
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
K030627 · C.R. Bard, Inc. · Oct 2003
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · Cordis Corp. · Apr 2000
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc. · Nov 1999
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997