EndoCATH 2006

GUDID M95520060

Intravascular occluding balloon catheter, image-guided

Primary Device ID	M95520060
NIH Device Record Key	be0cb07a-c564-4c72-8e2c-ee60389c889c
Commercial Distribution Status	In Commercial Distribution
Brand Name	EndoCATH
Version Model Number	2006
Catalog Number	2006
Company DUNS	068810802
Company Name	SENTREHEART, INC
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

Device Issuing Agency	Device ID
HIBCC	M95520060 [Primary]

DQY	Catheter, Percutaneous

Steralize Prior To Use	false
Device Is Sterile	true

M95520060 - EndoCATH	2023-12-04Large Occlusion Balloon Catheter
M95520060 - EndoCATH	2023-12-04 Large Occlusion Balloon Catheter
M95580020 - Tensure	2020-05-06 A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascula
M95550010 - SureCUT	2020-02-06 A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected sc

Mark Image Registration \| Serial	Company Trademark Application Date
ENDOCATH 77160003 3686539 Live/Registered	SentreHEART, Inc. 2007-04-18