PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET— 510(k) K914792

Substantially Equivalent

Filtertek, Inc.

FDA 510(k) clearance K914792 for PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET, Substantially Equivalent on 1992-01-15. Applicant: Filtertek, Inc..

Clearance details

Applicant: Filtertek, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1991-10-23
Decision date: 1992-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hebron, IL, 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.