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510(k) K200661

Steripath Micro Blood Collection System by Magnolia Medical Technologies, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
March 12, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Magnolia Medical Technologies, Inc.

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

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