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ALN Optional Vena Cava Filter - Brachial Approach
FDA UDIClass II (US FDA UDI)
by A.l.n.
Identity
- Trade Name
- ALN Optional Vena Cava Filter - Brachial Approach FDA UDI
- Generic Name
- Vena cava filter, temporary/permanent FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- FB.010500 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760017680028 FDA UDI
- 510(k) Number
- K163699 FDA UDI
- FDA Product Code
- DTK FDA UDI
- GMDN Term
- Vena cava filter, temporary/permanent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Vena cava filter, temporary/permanent
ALN Optional Vena Cava Filter - Brachial Approach by A.l.n. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vena cava filter, temporary/permanent.
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- Angel Catheter — Bio2 Medical, Inc. · Class II
- Gunther Tulip — COOK INCORPORATED · Class II
- Gunther Tulip — COOK INCORPORATED · Class II
- Gunther Tulip — COOK INCORPORATED · Class II
- Cook Celect — William Cook Europe ApS · Class II
Cleared under the same submission
K163699 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A.l.n.
Sources (1)
- FDA UDI a25327e7-3d9c-4fac-ab11-8483e387dc52 35 fields · synced Jun 6, 2026