Cleared Traditional

K061593 - ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM

K061593 is the FDA 510(k) clearance for ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM by AtriCure, Inc.. It is a Class 2 Cardiovascular device (product code OCL) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K061593 · AtriCure, Inc. · Cardiovascular device
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Jul 2006
Decision
34d
Days
Class 2
Risk

K061593 is an FDA 510(k) clearance for the ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K061593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date July 12, 2006
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K061593.
ATRICURE COOLRAIL LINEAR PEN
K073605 · AtriCure, Inc. · Mar 2008
ATRICURE BIPOLAR SYSTEM
K043579 · AtriCure, Inc. · Jul 2007
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
K070288 · Medtronic Vascular · Jun 2007
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459 · AtriCure, Inc. · Jun 2005
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · Medtronic Vascular · Jan 2002