FARAWAVE™ NAV M004PF41M412
GUDID 00191506043209
Pulsed Field Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
Cardiac irreversible electroporation system catheter| Primary Device ID | 00191506043209 |
| NIH Device Record Key | 117ef70e-6d2b-48ba-a2c6-98e3dd0a3d66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FARAWAVE™ NAV |
| Version Model Number | M004PF41M412 |
| Catalog Number | M004PF41M412 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506043209 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P230030
FDA Product Code
| QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-30 |
| Device Publish Date | 2024-10-22 |
On-Brand Devices [FARAWAVE™ NAV]
| 00191506043209 | Pulsed Field Ablation Catheter |
| 00191506043193 | Pulsed Field Ablation Catheter |
Trademark Results [FARAWAVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FARAWAVE 87622994 not registered Live/Pending |
FARAPULSE, INC. 2017-09-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.