Guidewire, Catheter, Reprocessed

Device Code: 902

Product Code(s): NKQ

Device Classification Information

• Device Type ID: 902
• Device Name: Guidewire, Catheter, Reprocessed
• Regulation Description: Catheter Guide Wire.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Structural Heart Devices Branch (SHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.1330 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NKQ
• 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: 902
• Device: Guidewire, Catheter, Reprocessed
• Product Code: NKQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Catheter Guide Wire.
• CFR Regulation Number: 870.1330 [🔎]

Device Problems
Material Fragmentation	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:44:38