IntellaNav MiFi™ XP M004MR4500K20

GUDID 08714729885726

Temperature Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter
Primary Device ID08714729885726
NIH Device Record Key716589a6-e69f-417c-912d-304c605f73a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntellaNav MiFi™ XP
Version Model NumberM004MR4500K20
Catalog NumberM004MR4500K20
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729885726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-09-15
Device Publish Date2016-03-18

On-Brand Devices [IntellaNav MiFi™ XP]

08714729885733Temperature Ablation Catheter
08714729885726Temperature Ablation Catheter
08714729885719Temperature Ablation Catheter

Trademark Results [IntellaNav MiFi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTELLANAV MIFI
INTELLANAV MIFI
86027367 5064562 Live/Registered
Boston Scientific Scimed, Inc.
2013-08-02

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