WATCHMAN FLX™ Pro M635WU60400

GUDID 00191506004637

Left Atrial Appendage Closure Device with Delivery System

BOSTON SCIENTIFIC CORPORATION

Cardiac defect occluder
Primary Device ID00191506004637
NIH Device Record Keya733804c-c409-41b9-b4ad-fdb71a382d6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameWATCHMAN FLX™ Pro
Version Model NumberM635WU60400
Catalog NumberM635WU60400
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506004637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGVSystem, appendage closure, left atrial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-01-12
Device Publish Date2023-09-12

On-Brand Devices [WATCHMAN FLX™ Pro]

00191506004637Left Atrial Appendage Closure Device with Delivery System
00191506004620Left Atrial Appendage Closure Device with Delivery System
00191506004613Left Atrial Appendage Closure Device with Delivery System
00191506004606Left Atrial Appendage Closure Device with Delivery System
00191506004590Left Atrial Appendage Closure Device with Delivery System
00191506004583Left Atrial Appendage Closure Device with Delivery System

Trademark Results [WATCHMAN FLX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WATCHMAN FLX
WATCHMAN FLX
97459003 not registered Live/Pending
Boston Scientific Scimed, Inc.
2022-06-15
WATCHMAN FLX
WATCHMAN FLX
88228883 not registered Live/Pending
Boston Scientific Scimed, Inc.
2018-12-13
WATCHMAN FLX
WATCHMAN FLX
87486602 not registered Dead/Abandoned
Atritech, Inc.
2017-06-13
WATCHMAN FLX
WATCHMAN FLX
86154069 not registered Dead/Abandoned
Atritech, Inc.
2013-12-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.