Identity
- Trade Name
- Comaneci Petit FDA UDI
- Generic Name
- Bare-metal intracranial vascular stent FDA UDI
- Device Name
- The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath. FDA UDI
- Model / Reference
- ANPP7188 FDA UDI
- Description
- The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290015107143 FDA UDI
- 510(k) Number
- DEN170064 FDA UDI
- FDA Product Code
- PUU FDA UDI
- GMDN Term
- Bare-metal intracranial vascular stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5955 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Bare-metal intracranial vascular stent
Comaneci Petit by Rapid Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN170064 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 |
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Manufacturer
- Manufacturer
- Rapid Medical Inc.
Sources (1)
- FDA UDI ed801e70-853a-4384-a17f-d4d7be33f0a4 34 fields · synced Jun 8, 2026