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FDA 510(k)

Dynamic Coronary Roadmap 2.0

K-Number: K172307 · 2017-10-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2017-10-24
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dynamic Coronary Roadmap 2.0 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-10-24 under approval number K172307. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamic Coronary Roadmap 2.0?

Dynamic Coronary Roadmap 2.0 is a medical device that received FDA 510(k) clearance on 2017-10-24. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K172307.

When was Dynamic Coronary Roadmap 2.0 approved by the FDA?

Dynamic Coronary Roadmap 2.0 received FDA 510(k) clearance on 2017-10-24, under approval number K172307.

What company makes Dynamic Coronary Roadmap 2.0?

Dynamic Coronary Roadmap 2.0 is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Dynamic Coronary Roadmap 2.0?

The FDA product code for Dynamic Coronary Roadmap 2.0 is OWB.

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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.

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