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510(k) K251812

Steripath® Flow™ Blood Collection System by Magnolia Medical Technologies — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
June 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Magnolia Medical Technologies

  • K222299 — Steripath Micro Blood Collection System (November 30, 2022)
  • K200661 — Steripath Micro Blood Collection System (October 8, 2020)
  • K192247 — Steripath Gen2 Blood Collection System (February 28, 2020)

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