- Physicians Office Resource

CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
Freezor® Xtra - 227F1

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

Special Storage Condition, Specify

Keep dry

Storage Environment Temperature - Degrees Fahrenheit

N/A
32.00

Device Sizes

Catheter curve size 49 mm

Catheter tip length 6 mm

Catheter shaft length 108 cm

Catheter shaft size 7 Fr

Catheter curve size 49 mm
Catheter tip length 6 mm
Catheter shaft length 108 cm
Catheter shaft size 7 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

Device Identifiers

Device Id: 00643169023536

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

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