NC TREK RX Coronary Dilatation Catheter +6 more— 510(k) K180040

Clearance details

Device name as filed

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

Applicant

Abbott Vascular

Product code

Code LOX

Device class

Class 2

Regulation

21 CFR 870.5100

Advisory panel

Cardiovascular

Date received

2018-01-05

Decision date

2018-08-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Santa Clara, CA, US

• K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter2026-08-14
• K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter2026-07-27
• K252116 — Firefighter Pro PTCA Balloon Catheter2026-04-07
• K254022 — FLASH Flex Aorto-Ostial Angioplasty System2026-04-02
• K252295 — Ryurei2026-03-27

• K220634 — NC TREK NEO Coronary Dilatation Catheter2022-06-30
• K221057 — Viatrac 14 Plus Peripheral Dilatation Catheter2022-05-05
• K201834 — HI-TORQUE PROCEED Guide Wire Family2020-07-30
• K200144 — HI-TORQUE Steelcore Bare Guide Wire2020-04-08
• K193126 — HI-TORQUE InfilTrac Guide Wire Family2019-12-11

Death

190

Injury

1,498

Malfunction

9,670

Total

11,358

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →