Zavation IBF System
K-Number: K181246 · 2018-07-10
ApplicantZavation Medical Products, LLC
Decision Date2018-07-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Zavation IBF System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2018-07-10 under approval number K181246. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zavation IBF System?
Zavation IBF System is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K181246.
When was Zavation IBF System approved by the FDA?
Zavation IBF System received FDA 510(k) clearance on 2018-07-10, under approval number K181246.
What company makes Zavation IBF System?
Zavation IBF System is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for Zavation IBF System?
The FDA product code for Zavation IBF System is MAX.
Other Devices by Zavation Medical Products, LLC
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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.