3D Auto LAA
K-Number: K201352 · 2020-08-17
ApplicantPhilips Health Care
Decision Date2020-08-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
3D Auto LAA is a medical device manufactured by Philips Health Care. It received FDA 510(k) clearance on 2020-08-17 under approval number K201352. 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 3D Auto LAA?
3D Auto LAA is a medical device that received FDA 510(k) clearance on 2020-08-17. It is manufactured by Philips Health Care. The 510(k) number is K201352.
When was 3D Auto LAA approved by the FDA?
3D Auto LAA received FDA 510(k) clearance on 2020-08-17, under approval number K201352.
What company makes 3D Auto LAA?
3D Auto LAA is manufactured by Philips Health Care.
What is the FDA product code for 3D Auto LAA?
The FDA product code for 3D Auto LAA is LLZ.
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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.