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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) 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. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K202212.

When did TruPlan receive FDA 510(k) clearance?

TruPlan received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202212.

Who is the listed applicant for TruPlan?

The FDA 510(k) record lists Circle Cardiovascular Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruPlan?

The FDA product code for TruPlan is LLZ.

Other records listing Circle Cardiovascular Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: 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.

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