Identity
- Trade Name
- Cardioblate™ FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- CLAMP 49321 CARDIOBLATE BP2 FT FDA UDI
- Model / Reference
- 49321 FDA UDI
- Description
- CLAMP 49321 CARDIOBLATE BP2 FT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169997998 FDA UDI
- 510(k) Number
- K182610 FDA UDI
- FDA Product Code
- OCL FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac radio-frequency ablation system generator
Cardioblate™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac radio-frequency ablation system generator.
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- Synergy™ Ablation System — ATRICURE, INC. · Class III
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
K182610 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
- Medtronic, Inc.
Sources (1)
- FDA UDI f6aab5f7-54f1-45de-95e3-99ce71f8035e 36 fields · synced May 31, 2026