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510(k) K874112

VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER by Van-Tec, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1988
Date Received
October 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Van-Tec, Inc.

  • 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)
  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K870696 — VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH (March 30, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)

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