Identity
- Trade Name
- Chilli II® FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Device Name
- Cooled Ablation Catheter FDA UDI
- Model / Reference
- M00490310 FDA UDI
- Description
- Cooled Ablation Catheter FDA UDI
Identifiers
- Catalog Number
- M00490310 FDA UDI
- Primary DI / UDI-DI
- 08714729452805 FDA UDI
- PMA Number
- P980003 FDA UDI
- FDA Product Code
- LPB FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system catheter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Chilli II® by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI ad1a0432-e072-408b-a6ed-e6201a19769d 37 fields · synced Jun 8, 2026