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510(k) K180040

NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter by Abbott Vascular — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2018
Date Received
January 5, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class
Class II
Regulation Number
870.5100
Review Panel
CV
Submission Type

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

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  • K200144 — HI-TORQUE Steelcore Bare Guide Wire (April 8, 2020)
  • K193126 — HI-TORQUE InfilTrac Guide Wire Family (December 11, 2019)
  • K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (July 25, 2019)
  • K173795 — HI-TORQUE TurnTrac Guide Wire Family (January 12, 2018)
  • K172394 — Steerable Guide Catheter (September 6, 2017)
  • K172073 — Hi-Torque Command 18 Guide Wire (August 25, 2017)
  • K161985 — Steerable Guide Catheter (August 7, 2016)

Other clearances for product code LOX

  • K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (January 17, 2026)
  • K242969 — Pantera Pro; Pantera LEO (October 25, 2024)
  • K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter (August 16, 2024)
  • K233505 — Sapphire ULTRA Coronary Dilatation Catheter (August 15, 2024)
  • K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
  • K223189 — Firefighter™ NC Pro PTCA Balloon Catheter (July 21, 2023)
  • K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Ballo (June 29, 2023)
  • K230705 — POT PTCA Balloon Dilatation Catheter (April 11, 2023)
  • K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter (February 15, 2023)
  • K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (December 21, 2022)