SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE— 510(k) K034059

Substantially Equivalent

Sectra AB

FDA 510(k) clearance K034059 for SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE, Substantially Equivalent on 2004-03-09. Applicant: Sectra AB.

Clearance details

Applicant: Sectra AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-12-31
Decision date: 2004-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, 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.