WATCHMAN® Access System M635TU10060

GUDID 08714729838197

Access Sheath with Dilator

BOSTON SCIENTIFIC CORPORATION

Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit
Primary Device ID08714729838197
NIH Device Record Key1c06a9b8-84c6-47d4-b10d-9548d11e3d08
Commercial Distribution StatusIn Commercial Distribution
Brand NameWATCHMAN® Access System
Version Model NumberM635TU10060
Catalog NumberM635TU10060
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 Identifiers

Device Issuing AgencyDevice ID
GS108714729838197 [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 Number5
Public Version Date2019-04-24
Device Publish Date2015-03-20

On-Brand Devices [WATCHMAN® Access System]

08714729838210Access Sheath with Dilator
08714729838203Access Sheath with Dilator
08714729838197Access Sheath with Dilator

Trademark Results [WATCHMAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WATCHMAN
WATCHMAN
98346451 not registered Live/Pending
Albaugh, LLC
2024-01-08
WATCHMAN
WATCHMAN
98176314 not registered Live/Pending
Saronic Technologies, Inc.
2023-09-12
WATCHMAN
WATCHMAN
98176312 not registered Live/Pending
Saronic Technologies, Inc.
2023-09-12
WATCHMAN
WATCHMAN
97762766 not registered Live/Pending
Winchester Metals, Inc.
2023-01-20
WATCHMAN
WATCHMAN
97176980 not registered Live/Pending
ALVARADO MANUFACTURING CO., INC.
2021-12-17
WATCHMAN
WATCHMAN
90624441 not registered Live/Pending
Boston Scientific Scimed, Inc.
2021-04-05
WATCHMAN
WATCHMAN
88232649 not registered Live/Pending
Rise Armament, Inc.
2018-12-17
WATCHMAN
WATCHMAN
87551103 5412456 Live/Registered
Wolo Manufacturing Corp.
2017-08-01
WATCHMAN
WATCHMAN
87384542 not registered Live/Pending
Hendrickson USA, L.L.C.
2017-03-24
WATCHMAN
WATCHMAN
86979742 5252029 Live/Registered
Gouldin Technologies, LLC
2016-02-17
WATCHMAN
WATCHMAN
86910391 not registered Live/Pending
Gouldin Technologies, LLC
2016-02-17
WATCHMAN
WATCHMAN
86795322 5083547 Live/Registered
HD Electric Company
2015-10-21

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