SMARTABLATE

SMARTABLATE - SAT001

A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 10846835009743

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