FARAWAVE™ M004PF41M432

GUDID 00191506043223

Pulsed Field Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac irreversible electroporation system catheter
Primary Device ID00191506043223
NIH Device Record Keyb53f88e6-0101-422f-94e0-f5664d7d691e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFARAWAVE™
Version Model NumberM004PF41M432
Catalog NumberM004PF41M432
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Gauge12 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506043223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QZIPercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-30
Device Publish Date2024-10-22

On-Brand Devices [FARAWAVE™]

00191506043155Pulsed Field Ablation Catheter
00191506043148Pulsed Field Ablation Catheter
00191506043223Pulsed Field Ablation Catheter
00191506043216Pulsed Field Ablation Catheter

Trademark Results [FARAWAVE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FARAWAVE
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.