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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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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

Safire™ Duo MediGuide Enabled™ - 05415067002402

MediGuide Enabled Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700240
In Commercial Distribution

  • 05415067002402 ()

  • Catheter Gauge: 8 French
A700240

  • Cardiac radio-frequency ablation system catheter

Safire™ Duo MediGuide Enabled™ - 05415067002396

MediGuide Enabled Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700239
In Commercial Distribution

  • 05415067002396 ()

  • Catheter Gauge: 8 French
A700239

  • Cardiac radio-frequency ablation system catheter

Safire™ Duo MediGuide Enabled™ - 05415067002389

MediGuide Enabled Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700238
In Commercial Distribution

  • 05415067002389 ()

  • Catheter Gauge: 8 French
A700238

  • Cardiac radio-frequency ablation system catheter

Safire™ Duo MediGuide Enabled™ - 05415067002372

MediGuide Enabled Ablation Catheter
IRVINE BIOMEDICAL, INC.
A700237
In Commercial Distribution

  • 05415067002372 ()

  • Catheter Gauge: 8 French
A700237

  • Cardiac radio-frequency ablation system catheter

Safire™ TX - 05414734300155

Ablation Catheter
IRVINE BIOMEDICAL, INC.
402839
In Commercial Distribution

  • 05414734300155 ()

  • Catheter Gauge: 7 French
402839

  • Cardiac radio-frequency ablation system catheter

Cool Point™ - 05414734258616

Tubing Set
IRVINE BIOMEDICAL, INC.
85785
In Commercial Distribution

  • 05414734258616 ()
85785

  • Cardiac ablation system irrigation tubing set

Arctic Front® - 00643169504837

CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169504837 ()

  • Length: 95.0 Centimeter
  • Balloon inflation size 23 mm
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
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