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FDA 510(k)

NC TREK NEO Coronary Dilatation Catheter

K-Number: K220634 · 2022-06-30

ApplicantAbbott Vascular
Decision Date2022-06-30
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NC TREK NEO Coronary Dilatation Catheter is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2022-06-30 under approval number K220634. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NC TREK NEO Coronary Dilatation Catheter?

NC TREK NEO Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Abbott Vascular. The 510(k) number is K220634.

When was NC TREK NEO Coronary Dilatation Catheter approved by the FDA?

NC TREK NEO Coronary Dilatation Catheter received FDA 510(k) clearance on 2022-06-30, under approval number K220634.

What company makes NC TREK NEO Coronary Dilatation Catheter?

NC TREK NEO Coronary Dilatation Catheter is manufactured by Abbott Vascular.

What is the FDA product code for NC TREK NEO Coronary Dilatation Catheter?

The FDA product code for NC TREK NEO Coronary Dilatation Catheter is LOX.

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Other Devices by Abbott Vascular

K161985Steerable Guide Catheter K172394Steerable Guide Catheter K172073Hi-Torque Command 18 Guide Wire K180040NC 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 K173795HI-TORQUE TurnTrac Guide Wire Family K193126HI-TORQUE InfilTrac Guide Wire Family

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Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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