Identity
- Trade Name
- Cook Celect FDA UDI
- Generic Name
- Vena cava filter, temporary/permanent FDA UDI
- Device Name
- Cook Celect, Vena Cava Filter, Jugular Approach FDA UDI
- Model / Reference
- G52909 FDA UDI
- Description
- Cook Celect, Vena Cava Filter, Jugular Approach FDA UDI
Identifiers
- Catalog Number
- IGTCFS-65-1-JUG-CELECT FDA UDI
- Primary DI / UDI-DI
- 10827002529097 FDA UDI
- 510(k) Number
- K090140 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Vena cava filter, temporary/permanent
Cook Celect by William Cook Europe ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vena cava filter, temporary/permanent.
- Simon Nitinol Filter™ — Bard Peripheral Vascular · Class II
- 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
- ALN Optional Vena Cava Filter - Brachial Approach — A.L.N. · Class II
- Crux® Vena Cava FIlter, Jugular — VOLCANO CORPORATION · Class II
- Denali® Vena Cava Filter — Bard Peripheral Vascular · Class II
Cleared under the same submission
K090140 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
- William Cook Europe ApS
Sources (1)
- FDA UDI d5c1f7e9-f36c-429d-a1ff-492eacaf25d2 37 fields · synced Jun 8, 2026