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FDA 510(k)

NC Quantum Apex PTCA Dilatation Catheter

K-Number: K160823 · 2016-06-23

ApplicantBoston Scientific Corporation
Decision Date2016-06-23
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NC Quantum Apex PTCA Dilatation Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-06-23 under approval number K160823. 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 Quantum Apex PTCA Dilatation Catheter?

NC Quantum Apex PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K160823.

When was NC Quantum Apex PTCA Dilatation Catheter approved by the FDA?

NC Quantum Apex PTCA Dilatation Catheter received FDA 510(k) clearance on 2016-06-23, under approval number K160823.

What company makes NC Quantum Apex PTCA Dilatation Catheter?

NC Quantum Apex PTCA Dilatation Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for NC Quantum Apex PTCA Dilatation Catheter?

The FDA product code for NC Quantum Apex PTCA Dilatation Catheter is LOX.

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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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