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510(k) K143087

Hospira Blood Set by Hospira, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2015
Date Received
October 27, 2014
Clearance Type
Traditional
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 Hospira, Inc.

  • K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (March 28, 2017)
  • K161036 — Hospira Extension Set, Hospira Primary Set (January 6, 2017)
  • K160492 — Hospira Sapphire Sets (December 6, 2016)
  • K160870 — Hospira Administration Sets (June 1, 2016)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K143015 — Hospira Primary Sets (February 25, 2015)
  • K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODU (January 16, 2015)
  • K142622 — IV Administration (January 15, 2015)
  • K142974 — Extension Sets (January 9, 2015)
  • K142433 — Hospira Extension Set (December 8, 2014)

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  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
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  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)