Cleared Traditional

NC TREK NEO Coronary Dilatation Catheter

K220634 · Abbott Vascular · Cardiovascular
Jun 2022
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K220634 is an FDA 510(k) clearance for the NC TREK NEO 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 June 30, 2022, 118 days after receiving the submission on March 4, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K220634 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2022
Decision Date June 30, 2022
Days to Decision 118 days
Submission Type Traditional
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.

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