Identity
- Trade Name
- Nanoparasol, Peel Away FDA UDI
- Generic Name
- Carotid artery embolic protection system FDA UDI
- Device Name
- Nanoparasol, Peel Away FDA UDI
- Model / Reference
- PNP4514C-190-01 FDA UDI
- Description
- Nanoparasol, Peel Away FDA UDI
Identifiers
- Catalog Number
- PNP4514C-190 FDA UDI
- Primary DI / UDI-DI
- 00842429117224 FDA UDI
- 510(k) Number
- K222694 FDA UDI
- FDA Product Code
- NTE FDA UDI
- GMDN Term
- Carotid artery embolic protection system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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: Carotid artery embolic protection system
Nanoparasol, Peel Away by Microvention Inc. — Class II — 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
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
- Neuroguard IEP® System — Contego Medical, Inc. · Class III
- MO.MA ULTRA — MEDTRONIC, INC. · Class II
Cleared under the same submission
K222694 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
- Microvention Inc.
Sources (1)
- FDA UDI e7593a21-efab-4499-9348-398dd3a2147e 37 fields · synced Jun 8, 2026