FDA 510(k)

NC Quantum Apex PTCA Dilatation Catheter

K-Number: K160823 · 2016-06-23

Decision Date2016-06-23

Product CodeLOX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NC Quantum Apex PTCA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-06-23 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K160823.

When did NC Quantum Apex PTCA Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for NC Quantum Apex PTCA Dilatation Catheter?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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)

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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.