HEART-LIFT BALLOON POSITIONER— 510(k) K982419

Substantially Equivalent

Cardiothoracic Systems, Inc.

FDA 510(k) clearance K982419 for HEART-LIFT BALLOON POSITIONER, Substantially Equivalent on 1999-01-13. Applicant: Cardiothoracic Systems, Inc..

Clearance details

Applicant: Cardiothoracic Systems, Inc.
Product code: Code MWS
Advisory panel: Cardiovascular
Date received: 1998-07-13
Decision date: 1999-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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Adverse events under product code MWS

product code MWS

Death: 4
Total: 4

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.