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510(k) Data Aggregation
K Number
K200266Device Name
BD Centro Vena Acute Central Line (7 French Dual Lumen)
Manufacturer
Bard Access Systems, Inc. (Bard has joined BD)
Date Cleared
2020-04-07
(64 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Bard Access Systems, Inc. (Bard has joined BD)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acute central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.
Device Description
A family of power injectable central venous catheters constructed of medical grade polyurethane and is designed for insertion into the central venous system. BD power injectable acute central lines are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with applicable insertion kit accessories. The maximum pressure injector settings and maximum power injection flow rate are specified in the table below:
Catheter Length | Lumen(s) | Power Injection Flow Rate | Maximum Power Injector Pressure Setting
---|---|---|---
16 cm and 20 cm | Distal | 10 mL/sec | 325 psi
| | Proximal | 10 mL/sec |
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K Number
K190855Device Name
BD Acute Central Line
Manufacturer
Bard Access Systems, Inc. (Bard has joined BD)
Date Cleared
2019-11-01
(213 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Bard Access Systems, Inc. (Bard has joined BD)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acute central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.
Device Description
A family of power injectable central venous catheters constructed of medical grade polyurethane and is designed for insertion into the central venous system. BD power injectable acute central lines are radiopaque, and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with applicable insertion kit accessories.
Ask a Question
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