Identity
- Trade Name
- NuVent ™ FDA UDI
- Generic Name
- Nasal/paranasal balloon catheter FDA UDI
- Device Name
- BALLOON SEEKER 1830717SPH EM SPHN 7X17MM FDA UDI
- Model / Reference
- 1830717SPH FDA UDI
- Description
- BALLOON SEEKER 1830717SPH EM SPHN 7X17MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169420489 FDA UDI
- 510(k) Number
- K132297 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Nasal/paranasal balloon catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 7.0 Millimeter FDA UDILength — 17.0 Millimeter FDA UDI
NuVent ™ by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K132297 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI e95bf7a0-0ade-4439-8887-62e080aeebb5 37 fields · synced May 30, 2026