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510(k) Data Aggregation
K Number
K152819Device Name
Amecath Peripheral inserted Central Venous Catheter Sets
Manufacturer
AMECO MEDICAL INDUSTRIES
Date Cleared
2016-02-05
(130 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
AMECO MEDICAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Amecath Peripheral Inserted Central Venous Catheter Sets are intended for use in attaining access to the central venous system for short or long-term use for venous pressure monitoring, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is indicated for multiple injections of contrast media through a power injector. The maximum pressure linetors used with the catheter may not exceed 300 psi and the flow rate may not exceed the maximum flow rate indicated.
Device Description
Not Found
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K Number
K131144Device Name
AMECO SHEATH INTRODUCER
Manufacturer
AMECO MEDICAL INDUSTRIES
Date Cleared
2013-08-15
(114 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
AMECO MEDICAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Percutaneous sheath introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature
Device Description
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K Number
K131814Device Name
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
Manufacturer
AMECO MEDICAL INDUSTRIES
Date Cleared
2013-07-26
(36 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
AMECO MEDICAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.
Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models:
- . PDLC
- . PYDLC
- P2TC
- . PXDLC
Catheters are not intended for pediatric use.
Device Description
"Amecath Dual Lumen Implanted Hemodialysis Catheter" is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.
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K Number
K123943Device Name
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
Manufacturer
AMECO MEDICAL INDUSTRIES
Date Cleared
2013-04-02
(103 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
AMECO MEDICAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.
Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models:
- . PDLC
- PYDLC .
- P2TC .
- PXDLC .
Catheters are not intended for pediatric use.
Device Description
"Amecath Dual Lumen Implanted Hemodialysis Catheter and Repair Kit"
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K Number
K110794Device Name
AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
Manufacturer
AMECO MEDICAL INDUSTRIES
Date Cleared
2011-12-21
(274 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
AMECO MEDICAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:
- Lack of usable peripheral IV sites .
- Central venous pressure monitoring .
- Total parenteral nutrition (TPN) .
- . Multiple infusions of fluids, medications, or chemotherapy
- Frequent blood sampling or receiving blood transfusions/blood products .
- . Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
- Injection of contrast media in pressure CVC only .
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 300psi.
Device Description
Not Found
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K Number
K110793Device Name
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
Manufacturer
AMECO MEDICAL INDUSTRIES
Date Cleared
2011-12-16
(269 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
AMECO MEDICAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for acute hemodialysis and apheresis. They may be inserted perculaneously and are idealy placed in the internal jugularyon and apricless. They may be inserted percuraneously and an the internal jugular is the preferred site the preferred site.
Device Description
"Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits
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