ClearanceBrief
Panels › General, Plastic Surgery › Product code OCL · Class 2

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

Regulation 878.4400

0510(k)s in 12 months (54 all time)
0recalls in 12 months (17 all time)
17recalls that name a 510(k)
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Top companies in OCL

DateFirm and productCodeLinked 510(k)
Apr 20, 2022Medtronic Perfusion Systems
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 dev
Open, Classified
OCLK121767
K200514
Sep 27, 2021Medtronic Perfusion Systems
Cardioblate CryoFlex Surgical Ablation Console
Open, Classified
OCLK123733
Oct 12, 2020MEDTRONIC ATS MEDICAL, INC.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation S
Terminated
OCLK123733
Oct 12, 2020MEDTRONIC ATS MEDICAL, INC.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation Sys
Terminated
OCLK123733
Oct 12, 2020MEDTRONIC ATS MEDICAL, INC.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation Sy
Terminated
OCLK123733
Oct 12, 2020MEDTRONIC ATS MEDICAL, INC.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgi
Terminated
OCLK123733
May 29, 2019AtriCure, Inc.
EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation
Terminated
OCLK142084
Jan 22, 2019AtriCure, Inc.
COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Terminated
OCLK113475
Jan 22, 2019AtriCure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Terminated
OCLK113475
Jan 22, 2019AtriCure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Terminated
OCLK113475
Jan 22, 2019AtriCure, Inc.
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Terminated
OCLK113475
Sep 22, 2016AtriCure, Inc.
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate c
Terminated
OCLK113475
Mar 6, 2013Atricure Inc
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Uni
Terminated
OCLK050459
K061593
Sep 27, 2010Cardima Inc
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
Terminated
OCLK022008
K060715
Sep 27, 2010Cardima Inc
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
Terminated
OCLK022008
K060715
Jun 7, 2010St. Jude Medical Atrial Fibrillation Division Inc
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablatio
Terminated
OCLK080292
Jan 30, 2009St. Jude Medical Inc
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, ac
Terminated
OCLK080292

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