Cleared Traditional

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

K182610 · Medtronic · Cardiovascular

Dec 2018

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K182610 is an FDA 510(k) clearance for the Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP 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 December 19, 2018, 89 days after receiving the submission on September 21, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K182610 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2018
Decision Date	December 19, 2018
Days to Decision	89 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