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510(k) K922989

WILTEK IRRIGAITON/ASPIRATION TUBE SET by Wiltek Medical, Inc. — Product Code BYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1994
Date Received
June 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Flexible, Connecting
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Wiltek Medical, Inc.

  • K990231 — WILTEK HOT BIOPSY FORCEPS (April 13, 1999)
  • K930419 — WILTEK BIOPSY FORCEPS (June 1, 1993)
  • K914881 — WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914882 — WILTEK BALLOON CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914132 — WILTEK ELECTROCAUTERY ACTIVE CORD (September 25, 1991)
  • K914131 — WILTEK ELECTROCAUTERY ADAPTOR (September 25, 1991)
  • K912122 — CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K910334 — ELECTROCAUTERY PROBE (February 21, 1991)
  • K894871 — WILTEK BILIARY STENT SET (December 21, 1989)

Other clearances for product code BYY

  • K960616 — VITAFLOW SUCTION/ASPIRATION TUBING SET (May 6, 1996)
  • K960218 — CONNECTING TUBING (March 28, 1996)
  • K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (January 24, 1996)
  • K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (January 24, 1996)
  • K955150 — MAXI-FLOW (January 23, 1996)
  • K911586 — GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (July 2, 1991)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K873463 — VAN DELLEN ASPIRATING TUBING (November 23, 1987)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (August 15, 1985)
  • K843470 — PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (November 16, 1984)