Cleared Traditional

K130827 - FIRMAP CATHETER

K130827 is an FDA 510(k) clearance for FIRMAP CATHETER, manufactured by Topera, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K130827 · Topera, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
219d
Days
Class 2
Risk

K130827 is an FDA 510(k) clearance for the FIRMAP CATHETER. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Topera, Inc. (St.Louis, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 219 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.

FDA 510(k) Submission Details - K130827

510(k) Number K130827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2013
Decision Date October 31, 2013
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MTD Device Classification - Class 2, Special Controls

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
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 - MTD Catheter, Intracardiac Mapping, High-density Array

All 33
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K130827.
FIRMap Catheter
K153093 · Abbott Electrophysiology · Apr 2016
FRIMAP ADAPTER CONNECTOR (MAC)
K142182 · Topera, Inc. · Sep 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · Biosense Webster, Inc. · Mar 2013
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · Biosense Webster, Inc. · May 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · St Jude Medical · May 2012