K034059

Substantially Equivalent

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE

Applicant: Sectra AB
Product 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

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.