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510(k) K023090

OPTION-VF URINARY CATHETER, FV14218 by Opticon Medical, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2003
Date Received
September 17, 2002
Clearance Type
Traditional
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)
  • K033830 — OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRA (January 9, 2004)
  • 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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