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510(k) K954284

MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) by Medi-Plast Intl., Inc. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1996
Date Received
August 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type

Other clearances by Medi-Plast Intl., Inc.

  • K873588 — 10CC CONTROL SYRINGE (October 23, 1987)
  • K863402 — MEDI-PLAST DISPOSABLE MANIFOLD (October 22, 1986)
  • K861785 — FLUOROSCOPE BAND BAG (June 13, 1986)
  • K851489 — ARTERIAL-VENOUS COMPRESSION DRESSING (June 11, 1985)
  • K842136 — STERILE PAN SET (July 6, 1984)
  • K840021 — OPERATING ROOM TRAY SET (March 15, 1984)
  • K840022 — HEART CATHETERIZATION TRAY SET (February 4, 1984)
  • K811234 — I.V. BOTTLE (RIDGID) (June 18, 1981)
  • K811268 — BOTTLE-TO-BOTTLE (June 18, 1981)
  • K811233 — I.V. PLASTIC BAG (June 17, 1981)

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  • K131124 — COLIGN (August 28, 2013)
  • K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE L (December 13, 2012)
  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (October 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (September 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (April 3, 2012)
  • K113148 — E-PASS (February 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (January 25, 2012)