SonoStik Guide Wire Introducer
K-Number: K243061 · 2024-11-04
ApplicantSonostik, LLC
Decision Date2024-11-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SonoStik Guide Wire Introducer is a medical device manufactured by Sonostik, LLC. It received FDA 510(k) clearance on 2024-11-04 under approval number K243061. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SonoStik Guide Wire Introducer?
SonoStik Guide Wire Introducer is a medical device that received FDA 510(k) clearance on 2024-11-04. It is manufactured by Sonostik, LLC. The 510(k) number is K243061.
When was SonoStik Guide Wire Introducer approved by the FDA?
SonoStik Guide Wire Introducer received FDA 510(k) clearance on 2024-11-04, under approval number K243061.
What company makes SonoStik Guide Wire Introducer?
SonoStik Guide Wire Introducer is manufactured by Sonostik, LLC.
What is the FDA product code for SonoStik Guide Wire Introducer?
The FDA product code for SonoStik Guide Wire Introducer is DYB.
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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.