Identity
- Trade Name
- FARAWAVE™ FDA UDI
- Generic Name
- Cardiac irreversible electroporation system catheter FDA UDI
- Device Name
- Pulsed Field Ablation Catheter FDA UDI
- Model / Reference
- M004PF41M401 FDA UDI
- Description
- Pulsed Field Ablation Catheter FDA UDI
Identifiers
- Catalog Number
- M004PF41M401 FDA UDI
- Primary DI / UDI-DI
- 00191506043148 FDA UDI
- PMA Number
- P230030 FDA UDI
- FDA Product Code
- QZI FDA UDI
- GMDN Term
- Cardiac irreversible electroporation system catheter FDA UDI
Classification
- Device Class
- Class III 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
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDI
Category: Cardiac irreversible electroporation system catheter
Farawave™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac irreversible electroporation system catheter.
- Globe® Catheter — Kardium, Inc. · Class III
- VARIPULSE™ Bi-Directional Catheter — Biosense Webster Inc · Class III
- PulseSelect™ — MEDTRONIC, INC. · Class III
- FARAWAVE™ — Boston Scientific · Class III
- FARAWAVE™ — Boston Scientific · Class III
- FARAWAVE™ — Boston Scientific · Class III
- FARAWAVE™ NAV — Boston Scientific · Class III
- FARAWAVE™ NAV — Boston Scientific · Class III
Cleared under the same submission
P230030 also covers:
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
- FARASTAR™ — Boston Scientific
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 357f4b14-454d-4f53-952c-c34726420450 36 fields · synced May 30, 2026