Cleared Traditional

K951347 - MARINR SERIES EP DIAGNOSTI CATHETERS

K951347 is an FDA 510(k) clearance for MARINR SERIES EP DIAGNOSTI 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 71-day FDA review.

K951347 · Medtronic Cardiorhythm · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
71d
Days
Class 2
Risk

K951347 is an FDA 510(k) clearance for the MARINR SERIES EP DIAGNOSTI 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 May 10, 1995 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Cardiorhythm devices

FDA 510(k) Submission Details - K951347

510(k) Number K951347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1995
Decision Date May 10, 1995
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 K951347.
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
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · Boston Scientific Corp · May 1995
CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933450 · Electro-Catheter Corp. · Apr 1995
OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933451 · Electro-Catheter Corp. · Apr 1995