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510(k) K930194

HEMOSTASIS VALVE AND TUBING SET by Opticon Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1993
Date Received
January 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
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)
  • K023090 — OPTION-VF URINARY CATHETER, FV14218 (March 19, 2003)
  • K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (May 16, 1997)
  • 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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