FDA 510(k)

IVUS PLUS

K-Number: K024103 · 2003-01-24

Decision Date2003-01-24

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IVUS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Indec Systems, Inc.. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K024103. 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 IVUS PLUS?

IVUS PLUS is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Indec Systems, Inc.. The 510(k) number is K024103.

When did IVUS PLUS receive FDA 510(k) clearance?

IVUS PLUS received FDA 510(k) clearance on 2003-01-24, under 510(k) number K024103.

Who is the listed applicant for IVUS PLUS?

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

What is the FDA product code for IVUS PLUS?

The FDA product code for IVUS PLUS is LLZ.

Other records listing Indec Systems, 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.

K092842ECHOPLAQUE K062985IVUS ENHANCER

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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.