Arterys Cardio DL
K-Number: K163253 · 2017-01-05
ApplicantArterys, Inc.
Decision Date2017-01-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Arterys Cardio DL is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2017-01-05 under approval number K163253. 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 Arterys Cardio DL?
Arterys Cardio DL is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Arterys, Inc.. The 510(k) number is K163253.
When was Arterys Cardio DL approved by the FDA?
Arterys Cardio DL received FDA 510(k) clearance on 2017-01-05, under approval number K163253.
What company makes Arterys Cardio DL?
Arterys Cardio DL is manufactured by Arterys, Inc..
What is the FDA product code for Arterys Cardio DL?
The FDA product code for Arterys Cardio DL is LLZ.
Other Devices by Arterys, Inc.
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.