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510(k) K922354

BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET by Med Institute, Inc. — Product Code GCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
May 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Med Institute, Inc.

  • K990034 — WILSON-COOK COLONIC Z-STENT (April 17, 2000)
  • K982507 — MINI POLYURETHANE CATHETER (September 16, 1998)
  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (April 17, 1998)
  • K971140 — VITAL-PORT INFUSION PAL (November 17, 1997)
  • K970442 — TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (April 30, 1997)
  • K945586 — FLEXIBLE DILATING SHEATH (April 4, 1997)
  • K960698 — NON-CORING NEEDLE (April 15, 1996)
  • K941228 — ENDOLUMINAL ACCESS TUBE (September 27, 1995)
  • K951077 — VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM (July 31, 1995)

Other clearances for product code GCC

  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K893480 — BYRD EXTRACTOR SET (June 23, 1989)
  • K820865 — VAN-TEC FASCIAL DILATOR (May 5, 1982)