Identity
- Trade Name
- CenterCross Ultra LV Catheter FDA UDI
- Generic Name
- Atheroma crossing microdissection catheter, coronary FDA UDI
- Device Name
- The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. FDA UDI
- Model / Reference
- LV-0100 FDA UDI
- Description
- The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B094LV01000 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Atheroma crossing microdissection catheter, coronary 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
No
FDA UDI
Category: Atheroma crossing microdissection catheter, coronary
CenterCross Ultra LV Catheter by Roxwood Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atheroma crossing microdissection catheter, coronary.
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- MultiCross Catheter — ROXWOOD MEDICAL, INC. · Class II
- CenterCross Catheter — ROXWOOD MEDICAL, INC. · Class II
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
- Roxwood Medical, Inc.
Sources (1)
- FDA UDI c68d0e6b-e5d6-4e84-8e22-8faf936bfd9b 33 fields · synced Jun 6, 2026