FDA UDI
In Commercial Distribution
🇺🇸 United States
FARAWAVE™
DI: 00191506043155
·
Model: M004PF41M402
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FARAWAVE™
- Primary DI
- 00191506043155
- Version / Model
- M004PF41M402
- Catalog Number
- M004PF41M402
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-14
- Public Version
- 1
- Public Version Date
- 2024-02-22
- Public Version Status
- New
- Public Device Record Key
- de43ca73-1b89-472f-bb61-bd14b0693556
Device Description
Pulsed Field Ablation Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65066 | Cardiac irreversible electroporation system catheter | A flexible tube with an electrode array its distal end designed to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to treat cardiac arrhythmia. It is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is designed to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506043155 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230030 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4 | Millimeter |