CATH 44516U SOLOIST US W/O CE

CATH 44516U SOLOIST US W/O CE
SOLOIST™ - 44516U

A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

• Electrode Spacing 5 mm
• Usable Length 110 cm
• Catheter Size 2.0 mm (6 Fr)

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DRF

Device Name: Catheter, Electrode Recording, Or Probe, Electrode Recording

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 870.1220

Third Party Flag: N

Medical Specialty: CV

Device Id: 00643169139602

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