Heraeus Peripheral Guidewire
K-Number: K191502 · 2019-11-26
ApplicantHeraeus Medical Components, LLC
Decision Date2019-11-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Heraeus Peripheral Guidewire is a medical device manufactured by Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2019-11-26 under approval number K191502. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Heraeus Peripheral Guidewire?
Heraeus Peripheral Guidewire is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Heraeus Medical Components, LLC. The 510(k) number is K191502.
When was Heraeus Peripheral Guidewire approved by the FDA?
Heraeus Peripheral Guidewire received FDA 510(k) clearance on 2019-11-26, under approval number K191502.
What company makes Heraeus Peripheral Guidewire?
Heraeus Peripheral Guidewire is manufactured by Heraeus Medical Components, LLC.
What is the FDA product code for Heraeus Peripheral Guidewire?
The FDA product code for Heraeus Peripheral Guidewire is DQX.
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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.