FDA 510(k)

vascuCAP

K-Number: K183012 · 2018-12-21

Decision Date2018-12-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

vascuCAP is the device name listed in this FDA 510(k) record. The listed applicant is Elucid Bioimaging, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K183012. 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 vascuCAP?

vascuCAP is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Elucid Bioimaging, Inc.. The 510(k) number is K183012.

When did vascuCAP receive FDA 510(k) clearance?

vascuCAP received FDA 510(k) clearance on 2018-12-21, under 510(k) number K183012.

Who is the listed applicant for vascuCAP?

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

What is the FDA product code for vascuCAP?

The FDA product code for vascuCAP is LLZ.

Other records listing Elucid Bioimaging, 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.

K241524Elucid PlaqueIQ K221463ElucidVivo A.3 K163071vascuCAP

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.