PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET— 510(k) K914792
Substantially EquivalentFiltertek, 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.. Device class: 2.
Clearance details
- Applicant
- Filtertek, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hebron, IL, US
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More clearances from Filtertek, Inc.
view allAdverse 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, through . 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.