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510(k) K963659

EXEL I.V. ADMINISTRATION SET by Exel Intl. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
September 3, 1996
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

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  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)
  • K895769 — EXEL HUBER NEEDLE (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)

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