Identity
- Trade Name
- CavaClear laser sheath FDA UDI
- Generic Name
- Vena cava filter extraction/repositioning kit FDA UDI
- Device Name
- 14F FDA UDI
- Model / Reference
- 500-514 FDA UDI
- Description
- 14F FDA UDI
Identifiers
- Catalog Number
- 500-514 FDA UDI
- Primary DI / UDI-DI
- 00813132022969 FDA UDI
- 510(k) Number
- DEN210024 FDA UDI
- FDA Product Code
- QRJ FDA UDI
- GMDN Term
- Vena cava filter extraction/repositioning kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5125 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Vena cava filter extraction/repositioning kit
CavaClear laser sheath by Philips Image Guided Therapy Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vena cava filter extraction/repositioning kit.
- RECOVERY CONE® — Bard Peripheral Vascular · Class II
- Bard Snare US — HERAEUS MEDICAL COMPONENTS LLC · Class II
- Triple-Loop Snare Retrieval Kit — Argon Medical Devices, Inc. · Class II
- Single-Loop Snare Retrieval Kit — Argon Medical Devices, Inc. · Class II
- RECOVERY CONE® — Bard Peripheral Vascular · Class II
- CavaClear laser sheath — Philips Image Guided Therapy Corporation · Class II
Cleared under the same submission
DEN210024 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
Sources (1)
- FDA UDI 96ca2043-59d5-4132-8acc-ef736f504d45 37 fields · synced Jun 9, 2026