Cleared Special

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

K180040 · Abbott Vascular · Cardiovascular

Aug 2018

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K180040 is an FDA 510(k) clearance for the 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, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Abbott Vascular (S,Mta Clara, US). The FDA issued a Cleared decision on August 24, 2018, 231 days after receiving the submission on January 5, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number	K180040 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2018
Decision Date	August 24, 2018
Days to Decision	231 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5100
Definition	A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.