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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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FlexAbility™ - 05415067011114

Ablation Catheter
ST. JUDE MEDICAL, INC.
A701125
In Commercial Distribution

  • 05415067011114 ()

  • Catheter Gauge: 8 French
A701125

  • Cardiac radio-frequency ablation system catheter

FlexAbility™ - 05415067011107

Ablation Catheter
ST. JUDE MEDICAL, INC.
A701124
In Commercial Distribution

  • 05415067011107 ()

  • Catheter Gauge: 8 French
A701124

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05415067004574

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path Duo SP
Not in Commercial Distribution

  • 05415067004574 ()

  • Catheter Gauge: 7 French
A700457

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05415067004567

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path™ Duo SP
Not in Commercial Distribution

  • 05415067004567 ()

  • Catheter Gauge: 7 French
A700456

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05415067004550

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path™ Duo SP
Not in Commercial Distribution

  • 05415067004550 ()

  • Catheter Gauge: 7 French
A700455

  • Cardiac radio-frequency ablation system catheter

Therapy™ - 05415067004543

Ablation Catheter
IRVINE BIOMEDICAL, INC.
Cool Path™ DUO SP
Not in Commercial Distribution

  • 05415067004543 ()

  • Catheter Gauge: 7 French
A700454

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002440

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700244
In Commercial Distribution

  • 05415067002440 ()

  • Catheter Gauge: 8 French
A700244

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002433

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700243
In Commercial Distribution

  • 05415067002433 ()

  • Catheter Gauge: 8 French
A700243

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002426

Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700242
In Commercial Distribution

  • 05415067002426 ()

  • Catheter Gauge: 8 French
A700242

  • Cardiac radio-frequency ablation system catheter

Cool Path™ - 05415067002419

Abalation Catheter
IRVINE BIOMEDICAL, INC.
A700241
In Commercial Distribution

  • 05415067002419 ()

  • Catheter Gauge: 8 French
A700241

  • Cardiac radio-frequency ablation system catheter
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