Cleared Traditional

K953185 - PLATINUM SERIES EP DIAGNOSTIC CATHETERS

K953185 is an FDA 510(k) clearance for PLATINUM SERIES EP DIAGNOSTIC CATHETERS, manufactured by Medtronic Cardiorhythm. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K953185 · Medtronic Cardiorhythm · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
280d
Days
Class 2
Risk

K953185 is an FDA 510(k) clearance for the PLATINUM SERIES EP DIAGNOSTIC CATHETERS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Medtronic Cardiorhythm (San Jose, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 280 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 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.

View all Medtronic Cardiorhythm devices

FDA 510(k) Submission Details - K953185

510(k) Number K953185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date April 15, 1996
Days to Decision 280 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 125d · This submission: 280d
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 112
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K953185.
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997
ARRHYTHMIA MAPPING SYSTEM (8100/8300)
K965066 · Cardiac Pathways Corp. · Aug 1997
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · Boston Scientific Corp · Mar 1996
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · Arrow Intl., Inc. · Nov 1995
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
K945229 · Arrow Intl., Inc. · Aug 1995