Identity
- Trade Name
- FRONTRUNNER FDA UDI
- Generic Name
- Atheroma crossing microdissection catheter, coronary FDA UDI
- Device Name
- FRONTRUNNER MODEL FBB46090 FDA UDI
- Model / Reference
- FBS3990 FDA UDI
- Description
- FRONTRUNNER MODEL FBB46090 FDA UDI
Identifiers
- Catalog Number
- FBS3990 FDA UDI
- Primary DI / UDI-DI
- 20705032028445 FDA UDI
- FDA Product Code
- PDU 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
Frontrunner by Cordis US Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atheroma crossing microdissection catheter, coronary.
- CenterCross Catheter, CE — ROXWOOD MEDICAL, INC. · Class II
- Tigereye — AVINGER, INC. · Class II
- CenterCross Ultra LV Catheter — ROXWOOD MEDICAL, INC. · Class II
- MultiCross Catheter, CE — ROXWOOD MEDICAL, INC. · Class II
- MultiCross Catheter — ROXWOOD MEDICAL, INC. · Class II
- Tigereye ST — AVINGER, INC. · Class II
- CenterCross Catheter — ROXWOOD MEDICAL, INC. · Class II
- CenterCross Ultra 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cordis US Corp.
Sources (1)
- FDA UDI 9a98c49b-ed4c-4c7d-946e-d1a67477476d 35 fields · synced May 30, 2026