FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815— 510(k) K100799

Substantially Equivalent

Contract Medical Intl. GmbH

FDA 510(k) clearance K100799 for FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815, Substantially Equivalent on 2011-02-25. Applicant: Contract Medical Intl. GmbH.

Clearance details

Applicant: Contract Medical Intl. GmbH
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2010-03-22
Decision date: 2011-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dresden, Sachsen, DE

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.