MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900— 510(k) K040385

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K040385 for MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900, Substantially Equivalent on 2004-04-07. Applicant: Quest Medical, Inc..

Clearance details

Applicant: Quest Medical, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2004-02-17
Decision date: 2004-04-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Allen, TX, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.