Identity
- Trade Name
- LumiGuide FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. FDA UDI
- Model / Reference
- LumiGuide Navigation Wire 3D Ultra FDA UDI
- Description
- Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. FDA UDI
Identifiers
- Catalog Number
- LGN35160A3DU FDA UDI
- Primary DI / UDI-DI
- 00884838111110 FDA UDI
- 510(k) Number
- K233853 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.035 Inch FDA UDILength — 160 Centimeter FDA UDI
Category: Peripheral vascular guidewire, manual
LumiGuide by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular guidewire, manual.
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- GO2WIRE™ — Merit Medical Systems, Inc. · Class II
- Merit Laureate® — Merit Medical Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class II
- Selectiva — HERAEUS MEDICAL COMPONENTS LLC · Class II
Cleared under the same submission
K233853 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 Medical Systems Nederland B.V.
Sources (1)
- FDA UDI 6e4a55ae-349b-493b-aaf0-390d45728d56 36 fields · synced Sep 18, 2026