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510(k) Data Aggregation
K Number
K052075Device Name
PROCEDUR-10
Manufacturer
AVANCA MEDICAL DEVICES, INC.
Date Cleared
2005-11-09
(100 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
AVANCA MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Procedur-10 device is intended to be used to inject fluids into, or withdraw fluids from, the body
Device Description
The Procedur-10 device is a piston syringe
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K Number
K042486Device Name
PROCEDUR 10 SYRINGE DEVICE
Manufacturer
AVANCA MEDICAL DEVICES, INC.
Date Cleared
2005-01-21
(130 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
AVANCA MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.
Device Description
The Procedur-10 device is a piston syringe
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K Number
K042487Device Name
PROCEDUR SF SAFETY SYRINGE DEVICE
Manufacturer
AVANCA MEDICAL DEVICES, INC.
Date Cleared
2005-01-21
(130 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
AVANCA MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Device Description
The Procedur-SF device is a piston safety syringe. The Procedur-SF device utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley.
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