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510(k) K895772

EXEL INDWELLING CATHETER by Exel Intl. — Product Code FDZ

K895772 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL INDWELLING CATHETER". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code FDZ (Attachment, Eyepiece, For Insertion Of Prescription Lens), a Class I device regulated under 21 CFR 876.1500. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
September 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Eyepiece, For Insertion Of Prescription Lens
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
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)
  • K895769 — EXEL HUBER NEEDLE (February 16, 1990)

Other clearances for product code FDZ

  • K852642 — CENTRAL VEIN CATHETERIZATION TRAY (January 16, 1986)

FDA data resources