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510(k) K862491

EXEL BUTTERFLY SCALP VEIN SET by Exel Intl. — Product Code FPA

K862491 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL BUTTERFLY SCALP VEIN SET". The FDA issued a decision of Substantially Equivalent on August 27, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1986
Date Received
July 1, 1986
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 Exel Intl.

  • K992290 — EXEL INJECTION PLUG WITH CAP (February 23, 2000)
  • K963658 — EXEL AVF SINGLE NEEDLE (May 5, 1998)
  • K963659 — EXEL I.V. ADMINISTRATION SET (December 16, 1997)
  • K926119 — EXEL HUBER INFUSION SET ROTATING WING (August 11, 1993)
  • K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) (November 21, 1990)
  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • 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)

FDA data resources