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510(k) K033328

NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT by Novosci Corp. — Product Code DTL

K033328 is an FDA 510(k) premarket notification submitted by Novosci Corp. for the device "NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT". The FDA issued a decision of Substantially Equivalent on January 16, 2004. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Novosci Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2004
Date Received
October 16, 2003
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 Novosci Corp.

  • K072499 — NOVOFLO CATHETER LT (October 30, 2007)
  • K063355 — D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW (July 27, 2007)
  • K033270 — NOVOSCI READY SYSTEM, MODEL RS-200 (February 13, 2004)

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