VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201— 510(k) K003551

Substantially Equivalent

Jostra AG

FDA 510(k) clearance K003551 for VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201, Substantially Equivalent on 2001-07-11. Applicant: Jostra AG.

Clearance details

Applicant: Jostra AG
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2000-11-17
Decision date: 2001-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.