CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Cryoflex Surgical Ablation System.

Pre-market Notification Details

Device IDK123733
510k NumberK123733
Device Name:CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MVS83 Mounds View,  MN  55112
ContactKari Christianson
CorrespondentKari Christianson
MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MVS83 Mounds View,  MN  55112
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-05
Decision Date2013-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169305106 K123733 000
00763000015008 K123733 000
00763000015015 K123733 000
00763000114619 K123733 000
00763000114626 K123733 000
00763000114633 K123733 000
00763000114640 K123733 000
00643169183841 K123733 000
00643169183865 K123733 000
00643169183889 K123733 000
00763000014995 K123733 000

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