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510(k) Data Aggregation
K Number
K052475Device Name
VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
Manufacturer
Date Cleared
2006-09-14
(370 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
VYGON US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An intravascular catheter, inserted peripherally for long-term administration of solutions for parenteral nutrition and/or administration of drugs
Device Description
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K Number
K033704Device Name
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
Manufacturer
Date Cleared
2004-05-27
(184 days)
Product Code
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
VYGON US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of . communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity.
- The shunting may be used for evaluation or treatment of normal pressure ● communicating hydrocephalus.
- A percutaneous lumbo-peritnoeal shunt is also useful in the management of . persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and transient CSF absorption defects, e.g. post meningitic or post-hemorrhagic hydrocephalus.
- Lumbar Drainage System is intended for use as a means of temporary external Eumbar Drainage Cyclinage Cyonitoring and collection of cerebrospinal fluid from the diversion, proboute metesigned for use with the Phoenix Fifth Ventricle Collection Bag.
Device Description
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K Number
K040707Device Name
PACKAGING TRAY AND COMPONENTS
Manufacturer
Date Cleared
2004-04-16
(29 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
VYGON US LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The packaging tray is intended to be used as a non-reusable protective pack, which allows EO sterilization of the product and maintains sterility for a specified length of time, and protects the product from damage during transport, delivery and storage.
Device Description
Packaging Tray and Accessories
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