15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set— 510(k) K191871

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K191871 for 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set, Substantially Equivalent on 2019-08-07. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2019-07-12
Decision date: 2019-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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.