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510(k) Data Aggregation
K Number
K122585Device Name
CRUX VENA CAVA FILTER SYSTEM
Manufacturer
Date Cleared
2013-01-17
(146 days)
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
CRUX BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Crux VCF System is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava (IVC) in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated .
- . Failure of anticoagulant therapy in thromboembolic diseases
- Emergency treatment following massive pulmonary embolism where anticipated benefits of . conventional therapy are reduced
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is . contraindicated
The Crux VCF may be removed according to the instructions contained in the Instructions for Use section "Optional Retrieval of the Crux VCF" in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach.
Device Description
The Crux VCF System is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The system consists of a self-expanding Nitinol filter delivered from a single-use, disposable 9Fr catheter, which can be used percutaneously to deploy the filter. The filter wireforms are composed of two opposing self-expanding Nitinol spiral elements connected at each end with Nitinol crimps. One end of each wireform is formed into a sinusoidal shaped retrieval tail to aid in retrieval of the filter using a snare. Each retrieval tail has an atraumatic plasma ball and a radiopaque tantalum marker band to facilitate visualization. There are five tissue anchors attached to the wireforms elements with Nitinol tubing. The filter is designed to treat IVC diameters of 17 to 28mm.
The Delivery Catheter for the Crux VCF is a disposable, 9Fr introducer-sheath-compatible, single-use Delivery Catheter. The filter is provided loaded in the Crux VCF System for jugular or femoral approach delivery. The Delivery Catheter is an over-the-wire system, 0.035" guidewire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The polyimide inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip and a radiopaque marker band. The outer shaft has a radiopaque marker band, a Touhy-Borst hemostasis valve and a one-way check-valve for flushing.
The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.
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K Number
K120402Device Name
CRUX VENA CAVA FILTER SYSTEM
Manufacturer
Date Cleared
2012-07-13
(156 days)
Product Code
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
CRUX BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Crux VCF System is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava (IVC) in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated .
- Failure of anticoagulant therapy in thromboembolic diseases .
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or . is contraindicated
The Crux VCF may be removed according to the instructions contained in the Instructions for Use section "Optional Retrieval of the Crux VCF" in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach.
Device Description
The Crux VCF System is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The system consists of a self-expanding Nitinol filter delivered from a single-use, disposable 9Fr catheter, which can be used percutaneously to deploy the filter. The filter wireforms are composed of two opposing self-expanding Nitinol spiral elements connected at each end with Nitinol crimps. One end of each wireform is formed into a sinusoidal shaped retrieval tail to aid in retrieval of the filter using a snare. Each retrieval tail has an atraumatic plasma ball and a radiopaque tantalum marker band to facilitate visualization. There are five tissue anchors attached to the wireforms elements with Nitinol tubing. The filter is designed to treat IVC diameters of 17 to 28mm.
The delivery catheter for the Crux VCF is a disposable, 9Fr introducer-sheathcompatible, single-use delivery catheter. The filter is provided loaded in the Crux VCF System for jugular or femoral approach delivery. The delivery catheter is an over-thewire system, 0.035" guidewire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip. The outer shaft has a radiopaque distal marker band, a Touhy-Borst hemostasis valve and a one-way checkvalve for flushing.
The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.
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Ask a specific question about this device
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