POSIDYNE I.V. FILTER/AIR ELIMINATOR— 510(k) K834381

Clearance details

Applicant

Pall Biomedical Products Co.

Product code

Code FPB

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1983-12-13

Decision date

1984-04-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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Other

1

Total

1

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 →