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510(k) K873463

VAN DELLEN ASPIRATING TUBING by Van Dellen, Ltd. — Product Code BYY

K873463 is an FDA 510(k) premarket notification submitted by Van Dellen, Ltd. for the device "VAN DELLEN ASPIRATING TUBING". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Van Dellen, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
August 28, 1987
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 Van Dellen, Ltd.

  • K873465 — VAN DELLEN BACTERIA FILTER (January 20, 1988)
  • K873464 — VAN DELLEN CANNULA (November 23, 1987)
  • K873462 — VAN DELLEN ASPIRATOR (September 25, 1987)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K873162 — VAN DELLEN RETROBULBAR NEEDLE (September 4, 1987)
  • K873164 — VAN DELLEN HEALON CANNULA (September 4, 1987)

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)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
  • K911586 — GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (July 2, 1991)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (August 15, 1985)
  • K843470 — PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (November 16, 1984)

FDA data resources