BLOWER/MISTER— 510(k) K983135

Substantially Equivalent

Cardiothoracic Systems, Inc.

FDA 510(k) clearance K983135 for BLOWER/MISTER, Substantially Equivalent on 1998-11-13. Applicant: Cardiothoracic Systems, Inc..

Clearance details

Applicant: Cardiothoracic Systems, Inc.
Product code: Code FQH
Advisory panel: General Hospital
Date received: 1998-09-08
Decision date: 1998-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.