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510(k) K960616

VITAFLOW SUCTION/ASPIRATION TUBING SET by Vital Concepts, Inc. — Product Code BYY

K960616 is an FDA 510(k) premarket notification submitted by Vital Concepts, Inc. for the device "VITAFLOW SUCTION/ASPIRATION TUBING SET". The FDA issued a decision of Substantially Equivalent on May 6, 1996. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Vital Concepts, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1996
Date Received
February 13, 1996
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 Vital Concepts, Inc.

  • K032832 — IRRIGATION SETS (September 26, 2003)
  • K930192 — VCI INSUFLATOR FILTER W/ TUBING (March 2, 1994)
  • K934382 — VCI SUCTION/IRRIGATION TUBING SET (February 1, 1994)

Other clearances for product code BYY

  • 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)
  • 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)

FDA data resources