Olea S.I.A. Neurovascular V1.0
K-Number: K223532 · 2023-06-06
ApplicantOlea Medical
Decision Date2023-06-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Olea S.I.A. Neurovascular V1.0 is a medical device manufactured by Olea Medical. It received FDA 510(k) clearance on 2023-06-06 under approval number K223532. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Olea S.I.A. Neurovascular V1.0?
Olea S.I.A. Neurovascular V1.0 is a medical device that received FDA 510(k) clearance on 2023-06-06. It is manufactured by Olea Medical. The 510(k) number is K223532.
When was Olea S.I.A. Neurovascular V1.0 approved by the FDA?
Olea S.I.A. Neurovascular V1.0 received FDA 510(k) clearance on 2023-06-06, under approval number K223532.
What company makes Olea S.I.A. Neurovascular V1.0?
Olea S.I.A. Neurovascular V1.0 is manufactured by Olea Medical.
What is the FDA product code for Olea S.I.A. Neurovascular V1.0?
The FDA product code for Olea S.I.A. Neurovascular V1.0 is LLZ.
Other Devices by Olea Medical
Related Devices (Code: LLZ)
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.