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510(k) K063180

ISECURE SYRINGE CARTRIDGE HOLDER by Hospira, Inc. — Product Code IQG

K063180 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "ISECURE SYRINGE CARTRIDGE HOLDER". The FDA issued a decision of Substantially Equivalent on December 11, 2006. The device falls under product code IQG (Adaptor, Holder, Syringe), a Class I device regulated under 21 CFR 890.5050. Hospira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2006
Date Received
October 19, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Holder, Syringe
Device Class
Class I
Regulation Number
890.5050
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)
  • K143087 — Hospira Blood Set (March 4, 2015)
  • 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)

Other clearances for product code IQG

  • K073555 — INSULIN PROTECTOR (July 11, 2008)
  • K072174 — INSUCOZI INSULIN VIAL COVER (January 25, 2008)

FDA data resources