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510(k) K031500

EXCEL PRIMARY SOLUTION SET by Exelint Intl. Co. — Product Code FPA

K031500 is an FDA 510(k) premarket notification submitted by Exelint Intl. Co. for the device "EXCEL PRIMARY SOLUTION SET". The FDA issued a decision of Substantially Equivalent on July 25, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Exelint Intl. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2003
Date Received
May 13, 2003
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 Exelint Intl. Co.

  • K092172 — EXEL I.V. EXTENSION SET (January 4, 2010)
  • K052103 — EXEL SECURE TOUCH II SAFETY SYRINGE (October 19, 2005)
  • K011754 — EXEL SECURETOUCH PTP SYRINGE (January 22, 2003)
  • K020533 — EXEL VACULET BLOOD COLLECTION SET (December 2, 2002)
  • K022406 — EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET (September 30, 2002)
  • K011757 — EXEL COMFORTPOINT INSULIN PEN NEEDLE (January 23, 2002)
  • K012879 — EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE (January 17, 2002)
  • K013037 — EXCEL A.V FISUTAL NEEDLE SET (December 7, 2001)
  • K011405 — EXEL INJECTION PLUG WITH CAP (September 27, 2001)
  • K010404 — EXEL I.V. ADMINISTRATION SET (August 30, 2001)

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