K061743

Substantially Equivalent

VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001

Applicant: Maquet Cardiopulmonary, AG
Product code: DTN
Advisory panel: Cardiovascular
Date received: 2006-06-21
Decision date: 2006-07-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hirrlingen, DE

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.