TruPlan
K-Number: K202212 · 2021-02-19
ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2021-02-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TruPlan is a medical device manufactured by Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2021-02-19 under approval number K202212. 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 TruPlan?
TruPlan is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Circle Cardiovascular Imaging, Inc.. The 510(k) number is K202212.
When was TruPlan approved by the FDA?
TruPlan received FDA 510(k) clearance on 2021-02-19, under approval number K202212.
What company makes TruPlan?
TruPlan is manufactured by Circle Cardiovascular Imaging, Inc..
What is the FDA product code for TruPlan?
The FDA product code for TruPlan is LLZ.
Other Devices by Circle Cardiovascular Imaging, 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.