IVUS PLUS— 510(k) K024103

Substantially Equivalent

Indec Systems, Inc.

FDA 510(k) clearance K024103 for IVUS PLUS, Substantially Equivalent on 2003-01-24. Applicant: Indec Systems, Inc..

Clearance details

Applicant: Indec Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2002-12-12
Decision date: 2003-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.