Home / 510(k) Clearances / K891077

510(k) K891077

MEDIVERSE PARENTERAL NUTRITION BAG by Mediflex Intl. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1989
Date Received
March 1, 1989
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 Mediflex Intl.

  • K915140 — PRIMARY DRESSING TRAY (February 11, 1992)
  • K900841 — HEMODIALYSIS TRANSDUCER PROTECTOR (May 15, 1990)
  • K884243 — BLOOD TUBING SET (December 8, 1988)
  • K863496 — MEDIFLEX TRANSDUCER PROTECTOR (September 23, 1986)
  • K855039 — MEDIFLEX INJECTION CAP (January 24, 1986)
  • K854346 — MEDIFLEX DISPOSABLE TUBING CLAMP (November 18, 1985)
  • K852106 — I.V. ADMINISTRATION SET (June 7, 1985)
  • K843126 — MEDIFLEX DRAINAGE BAG (October 4, 1984)

Other clearances for product code KPE

  • K251139 — KabiHelp® Uno; KabiHelp® Advance plus (January 9, 2026)
  • 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)
  • K193528 — Empty EVA Bag (July 22, 2020)
  • K190328 — HCT Empty EVA Container Pack (August 15, 2019)