FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER— 510(k) K955818

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K955818 for FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER, Substantially Equivalent on 1996-03-26. Applicant: Quest Medical, Inc..

Clearance details

Applicant: Quest Medical, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1995-12-26
Decision date: 1996-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allen, TX, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.