Device, Angioplasty, Laser, Coronary

Device Code: 1010

Product Code(s): LPC

Device Classification Information

• Device Type ID: 1010
• Device Name: Device, Angioplasty, Laser, Coronary
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Interventional Cardiology Devices Branch (ICDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: LPC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-268 IEC 60601-2-22 Edition 3.1 2012-10
  Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
• 12-273 IEC 60825-1 Edition 2.0 2007-03
  Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

Total Product Life Cycle

• Device Type ID: 1010
• Device: Device, Angioplasty, Laser, Coronary
• Product Code: LPC
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	7
Detachment Of Device Or Device Component	4
Material Protrusion / Extrusion	2
Device Displays Incorrect Message	2
Use Of Device Problem	1
Solder Joint Fracture	1
Detachment Of Device Component	1
Material Deformation	1
Pressure Problem	1
Insufficient Information	1
Incorrect Or Inadequate Test Results	1
Total Device Problems	22

Recalls
Manufacturer		Recall Class	Date Posted
1	Spectranetics Corporation	II	Nov-28-2016

TPLC Last Update: 2019-04-02 19:46:19