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Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14

by Summit Medical Ltd 510(k)

Active United States

510(k) K024097

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK024097 Date14 Feb 2003ClearedStatusActive

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  • Withdrawn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 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
CAC
Models / Variants
FDA applicant
Summit Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5830
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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