Crosstella OTW
K-Number: K160004 · 2016-04-29
ApplicantKANEKA Corporation
Decision Date2016-04-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Crosstella OTW is a medical device manufactured by KANEKA Corporation. It received FDA 510(k) clearance on 2016-04-29 under approval number K160004. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Crosstella OTW?
Crosstella OTW is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by KANEKA Corporation. The 510(k) number is K160004.
When was Crosstella OTW approved by the FDA?
Crosstella OTW received FDA 510(k) clearance on 2016-04-29, under approval number K160004.
What company makes Crosstella OTW?
Crosstella OTW is manufactured by KANEKA Corporation.
What is the FDA product code for Crosstella OTW?
The FDA product code for Crosstella OTW is LIT.
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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.