Catheter, Intracardiac Mapping, High-density, Reprocessed

Device Code: 908

Product Code(s): NLG

Device Classification Information

• Device Type ID: 908
• Device Name: Catheter, Intracardiac Mapping, High-density, Reprocessed
• Regulation Description: Electrode Recording Catheter Or Electrode Recording Probe.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Electrophysiology Devices Branch (CEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.1220 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NLG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 908
• Device: Catheter, Intracardiac Mapping, High-density, Reprocessed
• Product Code: NLG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Electrode Recording Catheter Or Electrode Recording Probe.
• CFR Regulation Number: 870.1220 [🔎]

TPLC Last Update: 2019-04-02 19:44:43