MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM— 510(k) K940838

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K940838 for MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM, Substantially Equivalent on 1994-08-18. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 1994-02-23
Decision date: 1994-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, 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.