XTRACT CATHETER SYSTEM— 510(k) K071529

Substantially Equivalent

Lumen Biomedical, Inc.

FDA 510(k) clearance K071529 for XTRACT CATHETER SYSTEM, Substantially Equivalent on 2007-08-10. Applicant: Lumen Biomedical, Inc..

Clearance details

Applicant: Lumen Biomedical, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2007-06-05
Decision date: 2007-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.