Cleared Traditional

CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814

K070288 · Medtronic Vascular · Cardiovascular
Jun 2007
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K070288 is an FDA 510(k) clearance for the CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814, a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II — Special Controls, product code OCL), submitted by Medtronic Vascular (Brooklyn Park, US). The FDA issued a Cleared decision on June 18, 2007, 139 days after receiving the submission on January 30, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K070288 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2007
Decision Date June 18, 2007
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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