Cleared Traditional

K061678 - PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25

K061678 is an FDA 510(k) clearance for PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, manufactured by Prorhythm. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K061678 · Prorhythm · Cardiovascular device
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Jan 2007
Decision
211d
Days
Class 2
Risk

K061678 is an FDA 510(k) clearance for the PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI.... Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Prorhythm (Ronkonkoma, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 211 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 Prorhythm devices

FDA 510(k) Submission Details - K061678

510(k) Number K061678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date January 12, 2007
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
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 133
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