A.L.N.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Filter, Intravascular, Cardiovascular (DTK) (9)

Premarket Exempt

Clear

ALN Optional Vena Cava Filter - Femoral Approach - 03760017680004 Catalog Number :

Device Description : The device is an Optional Vena Cava Filter - Femoral Kit. It consists of a nine The device is an Optional Vena Cava Filter - Femoral Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

ALN Optional Vena Cava Filter - Jugular Approach - 03760017680011 Catalog Number :

Device Description : The device is an Optional Vena Cava Filter - Jugular Kit. It consists of a nine The device is an Optional Vena Cava Filter - Jugular Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

ALN Optional Vena Cava Filter - Brachial Approach - 03760017680028 Catalog Number :

Device Description : The device is an Optional Vena Cava Filter - Brachial Kit. It consists of a nine The device is an Optional Vena Cava Filter - Brachial Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

ALN Optional Vena Cava Filter - Femoral Approach with Hook - 03760017680042 Catalog Number :

Device Description : The device is an Optional Vena Cava Filter - Femoral Kit with Hook. It consists The device is an Optional Vena Cava Filter - Femoral Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

ALN Optional Vena Cava Filter - Jugular Approach with Hook - 03760017680059 Catalog Number :

Device Description : The device is an Optional Vena Cava Filter - Jugular Kit with Hook. It consists The device is an Optional Vena Cava Filter - Jugular Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

ALN Optional Vena Cava Filter - Brachial Approach with Hook - 03760017680066 Catalog Number :

Device Description : The device is an Optional Vena Cava Filter - Brachial Kit with Hook. It consists The device is an Optional Vena Cava Filter - Brachial Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

ALN Straight RS - 03760017680103 Catalog Number :

Device Description : The device is a Straight Extraction Kit of ALN Vena Cava Filter including a punc The device is a Straight Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : No

Device Count : 1

ALN Pre-Curved RS - 03760017680110 Catalog Number :

Device Description : The device is a Pre-curved Extraction Kit of ALN Vena Cava Filter including a pu The device is a Pre-curved Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : No

Device Count : 1

ALN 2in1 - 03760017680127 Catalog Number :

Device Description : The device is a 2in1 Extraction Kit of ALN Vena Cava Filter including a puncture The device is a 2in1 Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

Device Class : 2

Duns Number: 272983094

Premarket Exempt : No

Product Code : DTK

Prescription Use : No

Device Count : 1

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