TactiCath™ Ablation Catheter, Sensor Enabled™ H702517

GUDID 05415067028174

Software Installation

ST. JUDE MEDICAL, INC.

Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter
Primary Device ID05415067028174
NIH Device Record Key2538a6de-0fd4-4aa8-99d7-98b8e4cfcb16
Commercial Distribution StatusIn Commercial Distribution
Brand NameTactiCath™ Ablation Catheter, Sensor Enabled™
Version Model NumberH702517
Catalog NumberH702517
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]
GS105415067028174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [TactiCath™ Ablation Catheter, Sensor Enabled™]

05415067029713Catheter Catalog Installation
05415067028181Software Installation
05415067028174Software Installation
05415067027870Catheter Catalog Installation

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