Dynamic Coronary Roadmap
K-Number: K170130 · 2017-06-02
Decision Date2017-06-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Dynamic Coronary Roadmap is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-06-02 under approval number K170130. 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?
Dynamic Coronary Roadmap is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K170130.
When was Dynamic Coronary Roadmap approved by the FDA?
Dynamic Coronary Roadmap received FDA 510(k) clearance on 2017-06-02, under approval number K170130.
What company makes Dynamic Coronary Roadmap?
Dynamic Coronary Roadmap is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Dynamic Coronary Roadmap?
The FDA product code for Dynamic Coronary Roadmap 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.