Cleared Abbreviated

CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C (K013392) - FDA 510(k) Clearance

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

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K013392 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (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.

View all Medtronic Vascular devices

Submission Details

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.

Device Classification

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 21
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K013392.
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc. · Jun 2012
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
K080509 · Medtronic, Inc. · May 2008
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
K070288 · Medtronic Vascular · Jun 2007