IntellaTip MiFi™ Open-Irrigated

GUDID 08714729848707

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 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 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 ID	08714729848707
NIH Device Record Key	bcfe2e6b-98ed-4a9c-9b08-8ddb97bd4539
Commercial Distribution Status	In Commercial Distribution
Brand Name	IntellaTip MiFi™ Open-Irrigated
Version Model Number	M004PM9620N40
Company DUNS	021717889
Company Name	BOSTON SCIENTIFIC CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729848707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P150005

FDA Product Code

OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2021-02-19
Device Publish Date	2017-03-13

On-Brand Devices [IntellaTip MiFi™ Open-Irrigated]

08714729848707	Ablation Catheter
08714729848691	Ablation Catheter
08714729848684	Ablation Catheter

Trademark Results [IntellaTip MiFi]

Mark Image Registration \| Serial	Company Trademark Application Date
INTELLATIP MIFI 97054414 not registered Live/Pending	Boston Scientific Scimed, Inc. 2021-09-30