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Found 4 results
510(k) Data Aggregation
K Number
K964663Device Name
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
Manufacturer
RMDS, INC.
Date Cleared
1997-12-11
(385 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RMDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.
Device Description
Not Found
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K Number
K973216Device Name
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
Manufacturer
RMDS, INC.
Date Cleared
1997-11-25
(90 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RMDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.
Device Description
FAVC-HH: Femoral Artery Vascular Clamp-Hand Held
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K Number
K970027Device Name
FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
Manufacturer
RMDS, INC.
Date Cleared
1997-08-08
(217 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RMDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Femoral Artery Vascular Clamp-Mobile is used to provide pressure hemostasis after the removal of arterial catheters following femoral catheterization procedures. The FAVC-M: Femoral Artery Vascular Clamp-Mobile is positioned prior to removal of femoral catheters and apply controlled pressure to the puncture site until hemostasis is complete.
Device Description
FAVC-M: Femoral Artery Vascular Clamp-Mobile
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K Number
K964662Device Name
FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
Manufacturer
RMDS, INC.
Date Cleared
1997-02-03
(74 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
RMDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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