Identity
- Trade Name
- Neuroguard IEP® System FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system FDA UDI
- Model / Reference
- NG-NV-6-40 FDA UDI
- Description
- The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system FDA UDI
Identifiers
- Catalog Number
- NG-NV-6-40 FDA UDI
- Primary DI / UDI-DI
- 00851616007651 FDA UDI
- PMA Number
- P240009 FDA UDI
- FDA Product Code
- NIM FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class III 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
MR Conditional FDA UDI
Category: Peripheral angioplasty balloon catheter, basicBare-metal carotid artery stentCarotid artery embolic protection system
Neuroguard IEP® System by Contego Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carotid artery embolic protection system.
- ENROUTE Transcarotid Neuroprotection System — SILK ROAD MEDICAL, INC. · Class II
- MO.MA ULTRA — MEDTRONIC, INC. · Class II
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- MO.MA ULTRA — MEDTRONIC, INC. · Class II
- MO.MA ULTRA — MEDTRONIC, INC. · Class II
- Nanoparasol, Peel Away — MICROVENTION INC. · Class II
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
Cleared under the same submission
P240009 also covers:
- Neuroguard IEP® System — Contego Medical, Inc.
- Neuroguard IEP® System — Contego Medical, Inc.
- Neuroguard IEP® System — Contego Medical, Inc.
- Neuroguard IEP® System — Contego Medical, Inc.
- Neuroguard IEP® System — Contego Medical, Inc.
- Neuroguard IEP® System — Contego Medical, Inc.
- Neuroguard IEP® System — Contego Medical, Inc.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Contego Medical, Inc.
Sources (1)
- FDA UDI 0e0f17ff-9170-4fd5-9ecb-eff8a8470eaa 36 fields · synced Jun 8, 2026