SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET— 510(k) K022477

Clearance details

Applicant

Summit Medical , Ltd.

Product code

Code CAK

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

2002-07-29

Decision date

2002-10-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stevenage Hertfordshire, GB

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Malfunction

476

Total

476

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 →