CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
Freezor® MAX - 239F5
Device Description
A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.
Environmental Conditions
- 85.00
- N/A
- 136.00
- -31.00
- Keep Dry
- 86.00
- 59.00
Device Sizes
- Catheter tip length 8mm
- Length: 90.0 Centimeter
- Catheter curve length 66mm
- Catheter shaft size 9 Fr
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LPB
Device Name: Cardiac Ablation Percutaneous Catheter
Device Class: 3
Physical State: N/A
Definition: This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Code: OAE
Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device Class: 3
Physical State: The device is an ablation catheter that features electrodes through which thermal energy is delivered.
Definition: For the treatment of atrial fibrillation.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation.
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: Heart
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00763000245481
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A