Identity
- Trade Name
- HexaPulse™ PF Generator FDA UDI
- Generic Name
- Cardiac irreversible electroporation system generator FDA UDI
- Device Name
- HexaPulse PF Generator EUDAMEDPF GEN AFR-00008 HEXAPULSE US PLX FDA UDI
- Model / Reference
- AFR-00008 EUDAMEDFDA UDI
- Description
- PF GEN AFR-00008 HEXAPULSE US PLX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000871901 EUDAMED00763000998363 FDA UDI
- Basic UDI-DI
- 0763000B00026298J EUDAMED
- PMA Number
- P240013 FDA UDI
- FDA Product Code
- QZI FDA UDIOAD FDA UDIOAE FDA UDI
- EMDN Code
- Z120101 ARTERIOTOMY ABLATORS EUDAMED
- GMDN Term
- Cardiac irreversible electroporation system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Cardiac irreversible electroporation system generator
HexaPulse™ PF Generator by Medtronic, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac irreversible electroporation system generator.
- FARASTAR™ — Boston Scientific · Class III
- FARASTAR™ — Boston Scientific · Class III
- FARASTAR™ — Boston Scientific · Class III
- FARASTAR™ — Boston Scientific · Class III
- FARASTAR™ — Boston Scientific · Class III
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Cleared under the same submission
P240013 also covers:
- HexaFlow™ Irrigation Pump — MEDTRONIC, INC.
- HexaFlow™ Irrigation Pump — MEDTRONIC, INC.
- HexaGen™ RF Generator — MEDTRONIC, INC.
- HexaGen™ RF Generator — MEDTRONIC, INC.
- HexaPulse™ PF Generator — MEDTRONIC, INC.
- Sphere-9™ — MEDTRONIC, INC.
- Sphere-9™ Catheter — MEDTRONIC, INC.
- Sphere-9™ Catheter — MEDTRONIC, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| 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
- Medtronic, Inc.
Sources (2)
- FDA UDI 2c2e6ad9-66e5-4522-aac2-716ee7c2b695 35 fields · synced Jul 17, 2026
- EUDAMED 4559ac1b-dbb0-4586-b128-635950a60f73 61 fields · synced Jul 17, 2026