Cleared Traditional

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

K190623 · Medtronic · Cardiovascular
May 2019
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K190623 is an FDA 510(k) clearance for the Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device, a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II — Special Controls, product code OCL), submitted by Medtronic (Minneapolis, US). The FDA issued a Cleared decision on May 30, 2019, 80 days after receiving the submission on March 11, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K190623 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2019
Decision Date May 30, 2019
Days to Decision 80 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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