Cleared Abbreviated

K013392 - CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C

Also marketed or referenced as:
CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

K013392 is an FDA 510(k) clearance for CARDIOBLATE SURGICAL ABLATION PEN, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Abbreviated 510(k) pathway after a 102-day FDA review.

K013392 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
102d
Days
Class 2
Risk

K013392 is an FDA 510(k) clearance for the CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C. 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 Vascular (Shoreview, US). The FDA issued a Cleared decision on January 25, 2002 after a review of 102 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K013392

510(k) Number K013392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date January 25, 2002
Days to Decision 102 days
Submission Type Abbreviated
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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Standards-based clearance path.

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 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K013392.
SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
K040690 · Cryocath Technologies, Inc. · Apr 2004
CARDIMA ABLATION SYSTEM
K022008 · Cardima, Inc. · Jan 2003
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K021010 · Endocare, Inc. · Jun 2002
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
K011988 · Cardiofocus, Inc. · Sep 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · Endocare, Inc. · Jun 2001
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
K974320 · Cryogen, Inc. · Feb 1998
K013392 · CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
Download PDF FDA Summary Medtronic Vascular