Cleared Traditional

K183547 - Marinr Steerable Intracardiac Electrode...

K183547 is the FDA 510(k) clearance for Marinr Steerable Intracardiac Electrode... by Medtronic. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K183547 · Medtronic · Cardiovascular device
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Jul 2019
Decision
222d
Days
Class 2
Risk

K183547 is an FDA 510(k) clearance for the Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intrac.... Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on July 30, 2019 after a review of 222 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.

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Submission Details

510(k) Number K183547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date July 30, 2019
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 96
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