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510(k) K010279

MEDISYSTEMS LUER ACCESS INJECTION SITE by Medisystems Corp. — Product Code FPA

K010279 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "MEDISYSTEMS LUER ACCESS INJECTION SITE". The FDA issued a decision of Substantially Equivalent on May 29, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Medisystems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2001
Date Received
January 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Medisystems Corp.

  • K062953 — MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE (February 12, 2007)
  • K002372 — ACCESS ALERT GAUGE (October 25, 2000)
  • K994306 — REVERSO (March 20, 2000)
  • K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS (January 6, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K971860 — MEDISYSTEMS DIALYSIS PRIMING SETS (August 18, 1997)
  • K963668 — MEDISYSTEMS PERITONEAL DIALYSIS SETS (August 15, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)
  • K953823 — ARTERIAL VENOUS BLOOD TUBING SET (September 23, 1996)
  • K932074 — MEDISYSTEMS APHERESIS NEEDLE WITH GUARD (February 18, 1994)

Other clearances for product code FPA

  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources