ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID— 510(k) K112917

Name: FDA 510(k) clearance K112917
Creator: U.S. Food and Drug Administration
Published: 2011-10-27

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K112917 for ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID, Substantially Equivalent on 2011-10-27. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2011-10-03
Decision date: 2011-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.