Identity
- Trade Name
- CVX-300®-P FDA UDI
- Generic Name
- Atherectomy excimer laser system FDA UDI
- Device Name
- Excimer Laser System FDA UDI
- Model / Reference
- CVX300P FDA UDI
- Description
- Excimer Laser System FDA UDI
Identifiers
- Catalog Number
- CVX300P FDA UDI
- Primary DI / UDI-DI
- M204CVX300PAA0 FDA UDI
- FDA Product Code
- LPC FDA UDI
- GMDN Term
- Atherectomy excimer laser system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Atherectomy excimer laser system
Cvx-300®-P by Spectranetics Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atherectomy excimer laser system.
- DABRA Laser System — Catheter Precision, Inc · Class II
- Excimer Laser System — Spectranetics Corporation · Class III
- Excimer Laser System — Spectranetics Corporation · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectranetics Corporation
Sources (1)
- FDA UDI b149d563-f4b7-4444-94ca-39169dbad109 35 fields · synced May 30, 2026