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510(k) K193528

Empty EVA Bag by Haemotronic S.P.A. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2020
Date Received
December 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Haemotronic S.P.A.

  • K210749 — Empty EVA Bag (August 19, 2021)
  • K921597 — CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 (February 24, 1995)
  • K921595 — Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 (December 24, 1992)
  • K921594 — HAEMOTROL MODEL #HT-SB/6 BURETTE SET (December 24, 1992)
  • K913361 — DRAIN/PRIMING/RECIRCULATION BAG (March 30, 1992)

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  • K252094 — eZSURE™ Empty Fluid Container (August 1, 2025)
  • K250459 — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 5 (April 18, 2025)
  • K241442 — eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (June 21, 2024)
  • K223674 — eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (September 1, 2023)
  • K222622 — Disposable Infusion Bag for Parenteral Nutrition (February 16, 2023)
  • K210749 — Empty EVA Bag (August 19, 2021)
  • K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (May 6, 2021)
  • K190328 — HCT Empty EVA Container Pack (August 15, 2019)
  • K190305 — Additive Cap (April 30, 2019)