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510(k) Data Aggregation
K Number
K163699Device Name
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
Manufacturer
ALN Implants Chirurgicaux
Date Cleared
2017-09-08
(253 days)
Product Code
DTK
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
ALN Implants Chirurgicaux
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook are indicated for the prevention of recurrent pulmonary embolism via placement 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; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook may be retrieved with the ALN Extraction and/or Repositioning Kit according to the Instructions For Use of these devices.
The ALN Optional Vena Cava Filter with Hook may be also retrieved with a Standard Gooseneck Snare according to the Instructions For Use of this medical device.
The ALN Extraction and/or Repositioning Kit is indicated for the removal of an implanted ALN Optional Vena Cava Filter and ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.
Device Description
The ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit consists of a 9 leg 316L stainless steel vena cava filter with or without a retrieval hook supplied with a delivery kit, and a retrieval kit with an 8 arm 316L stainless steel clamp. The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava of high risk patients. The filter design consists of legs with barbs that are intended to help stabilize the device inside the vein and prevent migration.
The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath. The insertion of the filter can be made by jugular, brachial or femoral approach with a 7F sheath. The retrieval can be made only by the jugular approach.
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K Number
K113124Device Name
ALN OPTIONAL VANA CAVA FILTER
Manufacturer
ALN IMPLANTS CHIRURGICAUX
Date Cleared
2012-11-09
(385 days)
Product Code
DTK
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
ALN IMPLANTS CHIRURGICAUX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava 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; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit.
The ALN Optional Vena Cava Filter with Hook may be retrieved with a standard GooseNeck Snare according to the instructions supplied in the Instruction For Use of this medical device.
Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter or ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.
Device Description
The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter with or without a retrieval hook sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvel/film pouches and the extraction kit is packaged alone in the same type of pouches.
The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.
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K Number
K070514Device Name
ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
Manufacturer
ALN IMPLANTS CHIRURGICAUX
Date Cleared
2008-01-30
(342 days)
Product Code
DTK
Regulation Number
870.3375Why did this record match?
Applicant Name (Manufacturer) :
ALN IMPLANTS CHIRURGICAUX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava 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; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The ALN optional filter may be removed according to the instructions supplied in the Instruction for Use of the ALN Extraction Kit.
Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.
Device Description
The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvek/film pouches and the extraction kit is packaged alone in the same type of pouches.
The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.
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