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.

View all Ep Medsystems, Inc. devices

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
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 133
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K033963.
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