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510(k) K800880

PLASTIC TUBING ADAPTERS 5-IN-1- by Harvard Laboratories — Product Code DTL

K800880 is an FDA 510(k) premarket notification submitted by Harvard Laboratories for the device "PLASTIC TUBING ADAPTERS 5-IN-1-". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Harvard Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 17, 1980
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 Harvard Laboratories

  • K822765 — SIGMOIDOSCOPE, FLEXIBLE (November 17, 1982)
  • K810573 — TUBE FEEDING SET (April 23, 1981)
  • K810574 — SUCTION COLLECTION BOTTLE, DISPOSABLE (April 21, 1981)
  • K800878 — SECONDARY I.V. TUBING SETS (June 17, 1980)
  • K800879 — CLEAR PLASTIC CONNECTING TUBES (June 17, 1980)
  • K800877 — ANESTHESIA EXTENSION TUBES (June 17, 1980)
  • K800881 — DISPOSABLE BERMAN AIRWAYS (May 8, 1980)

Other clearances for product code DTL

  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • K143429 — Passage Hemostasis Valve (December 22, 2014)
  • K140475 — ROTATING ADAPTERS (April 16, 2014)
  • 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)

FDA data resources