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Summit Medical Ltd Transfusion Filter, Model LF400 & Summit Medical Ltd Transfusion Filter with Administration Set

by Summit Medical Ltd United Kingdom 510(k)

510(k) K022477 Product code CAK

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022477 Date25 Oct 2002ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 9 Oct 2026)

Specification

510(k) · synced 9 Oct 2026

510(k) Number
FDA Product Code
CAK
FDA applicant
Summit Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Summit Medical Ltd

See all devices from Summit Medical Ltd →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K022477 24 fields · synced 9 Oct 2026