ENCORE 26 ADVANTAGE KIT— 510(k) K123214

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K123214 for ENCORE 26 ADVANTAGE KIT, Substantially Equivalent on 2012-11-13. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2012-10-15
Decision date: 2012-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.