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Found 27 results
510(k) Data Aggregation
K Number
K121105Device Name
NUTRISAFE 2 FEEDING TUBE
Manufacturer
VYGON CORP.
Date Cleared
2012-12-18
(250 days)
Product Code
FPD, GAS
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Device Description
The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.
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K Number
K100163Device Name
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
Manufacturer
VYGON CORP.
Date Cleared
2011-10-13
(631 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Device Description
The Nutrisafe 2 feeding tubes are a product line extension to the existing Nutrisafe 2 feeding tubes. The subject feeding tubes are available in several sizes and in two materials. The feeding system contains a unique connection that does not incorporate a luer, reducing the risk of inadvertently connecting to intravenous connectors. The locking connection reduces the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.
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K Number
K073493Device Name
HEPATOSTAT SET
Manufacturer
VYGON CORP.
Date Cleared
2008-05-06
(146 days)
Product Code
GAM, GDJ
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.
Device Description
The Hepatostat Set® is an absorbable compression device which allows to perform any type of hepatic resection, large or small, without any significant bleeding. It is made of four pre-perforated absorbable strips. These strips are connected together by twenty Safil® polyfilament ligatures introduced through the liver by a special tubular needle holder. Each suture is terminated by a stainless steel dart and already inserted into a stainless steel tubular needle holder, fitted to the liver thickness. Two clamps enable to bring together two strips.
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K Number
K070705Device Name
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
Manufacturer
VYGON CORP.
Date Cleared
2007-11-30
(261 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LATEX-FREE BIONECTOR is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latexfree Bionector is a Male/Female Luer, neutral displacement device. It does not displace fluid upon either connection or disconnection. Latex-free Bionector may be flushed with saline only or heparinized saline, in accordance with hospital protocol. The Latex-free Bionector is MR Conditional.
Device Description
The Latex-free Bionector is a multi-purpose, closed, needle-free IV connector to be used for the purpose of sampling, injection, or continuous infusion of fluids or drugs. The Latex-free Bionector has a disinfectable membrane (disinfection must be carried out before and after use) which closes automatically when the infusion line or the syringe is disconnected.
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K Number
K061796Device Name
HEPATOSTAT SET, MODEL 760X
Manufacturer
VYGON CORP.
Date Cleared
2006-11-02
(129 days)
Product Code
GAM, CLA, GDJ
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.
Device Description
The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced through the liver with a tubular needle.
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K Number
K061250Device Name
MULTICATH EXPERT
Manufacturer
VYGON CORP.
Date Cleared
2006-09-29
(148 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vygon Multicath Expert Catheter is intended for use in patients who require Short-term (less than 30 days) I.V. iherapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters are manufactured with a Pellethane-based AgION™ antimicrobial. The AglON™ uses silver as the antimicrobial agent.
Device Description
The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial function. The polyurethane catheters are impregnated with the silver ion-based antimicrobial agent AgION™ and are available in 2-, 3-, 4-, or 5-lumen catheters. Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antiseptic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.
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K Number
K060944Device Name
NUTRISAFE 2
Manufacturer
VYGON CORP.
Date Cleared
2006-09-15
(162 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.
Device Description
The Nutrisafe 2 is a complete system of feeding tubes and accessories. The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.
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K Number
K062425Device Name
LIFECATH S PICC AND MIDLINE CATHETER
Manufacturer
VYGON CORP.
Date Cleared
2006-09-15
(28 days)
Product Code
LJS, RIS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.
Device Description
The Lifecath S peripherally inserted central catheters and midline catheters are fabricated of barium impregnated silicone elastomer. The catheters are supplied with a guidewire to aid in insertion. The 60 cm PICC is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. The 20 cm midline catheter is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. Both catheters have a fixation hub and an extravascular extension line. The catheters are marked every centimeter from the hub to the proximal tip. The fixation hub is marked with the catheter French size, and the extension lines are marked with the gauge size. A clamp is attached to each extension line, and is marked with the priming volume.
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K Number
K052564Device Name
VYGON LEADER-FLEX
Manufacturer
VYGON CORP.
Date Cleared
2006-04-05
(198 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primary indication of the Leaderflex catheter is pressure monitoring in peripheral arteries. The device may also be used for venous access in pediatric patients.
Device Description
Not Found
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K Number
K052881Device Name
VYGON LATEX FREE BIONECTOR
Manufacturer
VYGON CORP.
Date Cleared
2006-03-02
(141 days)
Product Code
FOZ, CAT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
VYGON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Latex Free Bionector is a multi-purpose catheter accessory; a closed needieless system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latex Free Bionector is a Male/Female Luer device that displaces a positive bolus during disconnection of the Male Luer devices connected to it.
Device Description
The Latex Free Bionector is a multi-purpose, closed, needle-free IV connection accessory for sampling, injection or continuous infusion of fluids or drugs.
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