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510(k) Data Aggregation
K Number
K072299Device Name
POWRSYRINGE ASPIRATOR
Manufacturer
PINYONS MEDICAL TECHNOLOGY, INC.
Date Cleared
2007-10-04
(48 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
PINYONS MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from, the body.
Device Description
The PowrSyringe Aspirator is a single use manual hand-held general-purpose piston syringe with handles to inject fluids into, or aspirate fluid from. The PowrSyringe Aspirator handles allow the user to pull the plunger back within the barrel when the user squeezes the handles. Users may open the PowrSyringe Aspirator's handles to inject fluids back into the barrel.
The PowrSyringe Aspirator safety features include:
- Clear barrel for visualization of air bubbles.
- Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
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K Number
K072318Device Name
POWRSYRINGE INJECTOR
Manufacturer
PINYONS MEDICAL TECHNOLOGY, INC.
Date Cleared
2007-09-21
(32 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
PINYONS MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.
Device Description
The PowrSyringe Injector is a single use manual hand-held piston syringe with handles to inject fluids into, or aspirate fluid from, the body including use in angiography. The PowrSyringe Injector handles allow the user to push the blunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Injector's handles to aspirate fluid back into the barrel.
The PowrSyringe Injector safety features include:
- Clear barrel for visualization of air bubbles. a
- I Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- 트 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
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K Number
K072345Device Name
POWRSYRINGE MONITOR
Manufacturer
PINYONS MEDICAL TECHNOLOGY, INC.
Date Cleared
2007-09-21
(31 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
PINYONS MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowrSyringe Monitor is a piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography.
Device Description
The PowrSyringe Monitor is a single use manual hand-held piston syringe with handles and a pressure gauge to inject fluids and monitor the pressure of that fluid including use in inflation and discography. The PowrSyringe Monitor handles allow the user to push the plunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Monitor's handles to aspirate fluid back into the barrel.
The PowrSyringe Monitor safety features include:
- Clear barrel for visualization of air bubbles.
- Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
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