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510(k) K820865

VAN-TEC FASCIAL DILATOR by Van-Tec, Inc. — Product Code GCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1982
Date Received
March 29, 1982
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 Van-Tec, Inc.

  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)

Other clearances for product code GCC

  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K922354 — BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (July 30, 1992)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K893480 — BYRD EXTRACTOR SET (June 23, 1989)