510(k) K033328

Device: NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
Applicant: Novosci Corp.
510(k) number: K033328
Product code: DTL
Decision: Substantially Equivalent (SESE)
Decision date: 2004-01-16
Date received: 2003-10-16
Regulation: 870.4290
Classification name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

510(k), Device, Applicant table
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K143429	Passage Hemostasis Valve	Merit Medical Systems, Inc.	2014-12-22
K140475	ROTATING ADAPTERS	Merit Medical Systems, Inc.	2014-04-16
K131124	COLIGN	Jilin Coronado Medical , Ltd.	2013-08-28
K123448	AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE	Medtronic, Inc.	2012-12-13
K122811	CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE	Medtronic, Inc.	2012-10-12
K122301	GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE	Vascular Solutions Zerusa , Ltd.	2012-09-07
K120069	MEDLINE STOPCOCK AND MANIFOLD	Medline Industries, Inc.	2012-04-03
K113148	E-PASS	Synexmed(Shenzhen)Company Limited	2012-02-28
K113845	TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE	Medtronic, Inc.	2012-01-25
K113132	DISPOSABLE HEMOSTATIC Y-CONNECTORS	Coeur, Inc.	2012-01-20
K113667	CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING	Edwards Lifesciences, LLC	2012-01-12
K101113	GUARDIAN II NC HEMOSTASIS VALVE	Zerusa Limited	2010-05-21
K093992	TERUMO LAUER LOCK ADAPTER	Terumo Cardiovascular Systems Corporation	2010-05-19
K100319	MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L	Merit Medical Systems, Inc.	2010-04-28