POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330— 510(k) K080332

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K080332 for POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330, Substantially Equivalent on 2008-09-05. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2008-02-07
Decision date: 2008-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

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Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

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.