VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA— 510(k) K140641

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K140641 for VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA, Substantially Equivalent on 2014-07-03. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2014-03-12
Decision date: 2014-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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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.