Search Results
Found 41 results
510(k) Data Aggregation
K Number
K130131Device Name
EDRAIN CHEST DRAINAGE SYSTEM
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2013-02-28
(41 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Evacuate air and/or fluid from the chest cavity or mediastinum
Help re-establish lung expansion and restore breathing dynamics
Facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
Device Description
Not Found
Ask a Question
K Number
K122138Device Name
ATRIUM FLIXENE IFG VASCULAR GRAFT
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2012-08-17
(29 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Atrium Graduated Wall Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Device Description
Atrium Graduated Wall Flixene IFG Graft
Ask a Question
K Number
K121070Device Name
C-QUR RPM MESH
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2012-04-26
(17 days)
Product Code
FTL, OXA
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atrium C-QUR RPM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.
Device Description
Not Found
Ask a Question
K Number
K113112Device Name
CLEARWAY RX NB CATHETER
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2011-11-17
(28 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearWay™ RX NB is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.
Device Description
Not Found
Ask a Question
K Number
K102596Device Name
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2010-10-05
(26 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Device Description
Not Found
Ask a Question
K Number
K093431Device Name
CLEARWAY OTW MODEL 85912
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2010-04-20
(167 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.
Device Description
ClearWay OTW catheter
Ask a Question
K Number
K100076Device Name
ATRIUM C-QUR OVT MESH
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2010-01-26
(14 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Atrium C-Qur TM OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.
Device Description
The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.
Ask a Question
K Number
K090909Device Name
C-QUR V -PATCH MESH
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2009-06-04
(64 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atrium C-QUR V-Patch™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
Device Description
Not Found
Ask a Question
K Number
K082748Device Name
ATRIUM PROLITE S MESH
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2009-01-14
(117 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atrium ProLite S Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
Device Description
Not Found
Ask a Question
K Number
K081718Device Name
EXPRESS CHEST DRAIN
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2008-07-25
(37 days)
Product Code
KDQ
Regulation Number
880.6740Why did this record match?
Applicant Name (Manufacturer) :
ATRIUM MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To evacuate air and/or fluid from the chest cavity or mediastinum.
To help re-establish lung expansion and restore breathing dynamics.
To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
Device Description
Atrium Medical Corporation Express™ Chest Drain
Ask a Question
Page 1 of 5