REMOTE CONTROL PSRC100 PFA 10 FT US
PulseSelect™ - PSRC100
Device Description
A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to allow a healthcare provider to control the operational functions of a cardiac irreversible electroporation system and its components (e.g., cardiac tissue ablation catheter) from a distance via a connected cable.
Environmental Conditions
- Keep Dry
Device Sizes
- Length: 10.0 Feet
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QZI
Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Device Class: 3
Physical State: The device is an ablation catheter that features electrodes through which pulsed electric fields are 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: N
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: 00763000617745
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