Cleared Traditional

K123733 - CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM

K123733 is an FDA 510(k) clearance for CARDIOBLATE CRYOFLEX SURGICAL ABLATION ..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K123733 · Medtronic, Inc. · Cardiovascular device
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Apr 2013
Decision
117d
Days
Class 2
Risk

K123733 is an FDA 510(k) clearance for the CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 1, 2013 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - 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, Inc. devices

FDA 510(k) Submission Details - K123733

510(k) Number K123733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2012
Decision Date April 01, 2013
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCL Device Classification - Class 2, Special Controls

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
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 - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 38
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K123733.
Coolrail Linear Pen
K183065 · AtriCure, Inc. · Dec 2018
Isolator Multifunctional Linear Pen
K163408 · AtriCure, Inc. · Jan 2017
ISOLATOR LINEAR PEN
K130521 · AtriCure, Inc. · Apr 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
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COOLRAIL LINEAR PEN MODEL MCRI
K122611 · AtriCure, Inc. · Sep 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012