WATCHMAN FXD Curve™ Access System M635TU80020

GUDID 00191506013813

Access Sheath with Dilator

BOSTON SCIENTIFIC CORPORATION

Cardiac occluder delivery kit
Primary Device ID00191506013813
NIH Device Record Keyb7e92011-d3f2-446a-98a0-7ed245a959f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameWATCHMAN FXD Curve™ Access System
Version Model NumberM635TU80020
Catalog NumberM635TU80020
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

Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter
Length75 Centimeter
Outer Diameter5 Millimeter
Lumen/Inner Diameter4.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506013813 [Primary]

FDA Product Code

DQYCatheter, percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-20
Device Publish Date2021-09-10

On-Brand Devices [WATCHMAN FXD Curve™ Access System]

00191506013813Access Sheath with Dilator
00191506013806Access Sheath with Dilator

Trademark Results [WATCHMAN FXD Curve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WATCHMAN FXD CURVE
WATCHMAN FXD CURVE
90623854 not registered Live/Pending
Boston Scientific Scimed, Inc.
2021-04-05

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