Cleared Special

K033963 - EP DEFLECTABLE CATHETERS

K033963 is an FDA 510(k) clearance for EP DEFLECTABLE CATHETERS, manufactured by Ep Medsystems, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 115-day FDA review.

K033963 · Ep Medsystems, Inc. · Cardiovascular device
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Apr 2004
Decision
115d
Days
Class 2
Risk

K033963 is an FDA 510(k) clearance for the EP DEFLECTABLE CATHETERS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Ep Medsystems, Inc. (West Berlin, US). The FDA issued a Cleared decision on April 15, 2004 after a review of 115 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. 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. Standard predicate reliance. 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 - K033963

510(k) Number K033963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date April 15, 2004
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 K033963.
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K033963 · EP DEFLECTABLE CATHETERS
Download PDF Ep Medsystems, Inc.