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510(k) K210749

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2021
Date Received
March 12, 2021
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.

  • K193528 — Empty EVA Bag (July 22, 2020)
  • 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)

Other clearances for product code KPE

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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)
  • K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (May 6, 2021)
  • K193528 — Empty EVA Bag (July 22, 2020)
  • K190328 — HCT Empty EVA Container Pack (August 15, 2019)
  • K190305 — Additive Cap (April 30, 2019)