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510(k) K884243

BLOOD TUBING SET by Mediflex Intl. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1988
Date Received
October 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Mediflex Intl.

  • K915140 — PRIMARY DRESSING TRAY (February 11, 1992)
  • K900841 — HEMODIALYSIS TRANSDUCER PROTECTOR (May 15, 1990)
  • K891077 — MEDIVERSE PARENTERAL NUTRITION BAG (May 24, 1989)
  • 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 FJK

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  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)