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510(k) K033830

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 by Opticon Medical, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2004
Date Received
December 10, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Opticon Medical, Inc.

  • K041983 — OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 (November 17, 2004)
  • K023090 — OPTION-VF URINARY CATHETER, FV14218 (March 19, 2003)
  • K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (May 16, 1997)
  • K930194 — HEMOSTASIS VALVE AND TUBING SET (September 22, 1993)
  • K904999 — WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE (January 26, 1993)
  • K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT (February 22, 1990)
  • K895476 — OPTION EPIDURAL CATHETERS (January 19, 1990)

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