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Found 11 results
510(k) Data Aggregation
K Number
K233702Device Name
SMARxT Tubing and Connectors
Manufacturer
Livanova USA Inc
Date Cleared
2024-08-08
(265 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
Device Description
The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.
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K Number
K150542Device Name
Terumo Pump Tubing
Manufacturer
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Date Cleared
2015-05-01
(59 days)
Product Code
DWE, DWF
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
Device Description
The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP). The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal). The 68D PVC Pump Tubing will have a Shore A nominal durometer of 68D while the predicate device, the 70D PVC Pump Tubing, has a Shore A nominal durometer of 70D. The durometer dictates the hardness of the tubing. There are no internal markings on the subject tubing. Outside markings consist of the Terumo symbol, followed by inner diameter (in inches) x wall thickness (in inches), durometer, and TCVS part number.
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K Number
K142607Device Name
AngioVac Circuit
Manufacturer
ANGIODYNAMICS
Date Cleared
2014-12-11
(87 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
Device Description
The AngioVac Circuit is an extracorporeal perfusion set that includes four subassemblies including a main perfusion circuit (manufactured of 0.375" non-DEHP PVC coextruded tubing with Y-connector, tubing quick-connects and priming line), waste line, tuohy adapter and reinfusion cannula connector. An extra reinfusion cannula connector and tuohy adapter are provided in a sealed pouch with the circuit.
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K Number
K092486Device Name
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
Manufacturer
VORTEX MEDICAL INC
Date Cleared
2009-08-28
(15 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
Device Description
The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").
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K Number
K080592Device Name
HLM TUBING SET WITH BIOLINE COATING
Manufacturer
MAQUET CARDIOPULMONARY AG
Date Cleared
2008-09-11
(192 days)
Product Code
DWE, DTL, DWF
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
Device Description
The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and it's components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
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K Number
K053025Device Name
JOSTRA HLM TUBING SET
Manufacturer
MAQUET CARDIOPULMONARY AG
Date Cleared
2005-11-10
(14 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
Device Description
The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours.
Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit.
The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter.
The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.
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K Number
K022857Device Name
PUMP TUBING WITH X-COATING
Manufacturer
Terumo Cardiovascular Systems Corporation
Date Cleared
2002-09-19
(22 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
Device Description
Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC). Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.
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K Number
K013578Device Name
PUMP TUBING
Manufacturer
TERUMO CARDIOVASCULAR SYSTEMS CORP.
Date Cleared
2002-01-22
(85 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.
The tubing is intended for use in procedures lasting up to 6-hours in duration.
Device Description
Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.
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K Number
K993189Device Name
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
Manufacturer
TERUMO CORP.
Date Cleared
2000-03-01
(160 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
Device Description
Cardiopulmonary Bypass Pump Tubing
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K Number
K993062Device Name
CHEST DRAINAGE TUBING
Manufacturer
OLSON MEDICAL SALES, INC.
Date Cleared
1999-12-10
(88 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Product Code :
DWE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.
Device Description
The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".
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