EndoCATH 2006

GUDID M95520060

Large Occlusion Balloon Catheter

SENTREHEART, INC

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided
Primary Device IDM95520060
NIH Device Record Keybe0cb07a-c564-4c72-8e2c-ee60389c889c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoCATH
Version Model Number2006
Catalog Number2006
Company DUNS068810802
Company NameSENTREHEART, INC
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

Customer Support Contacts

Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com
Phone1-855-256-7330
Emailinfo@sentreheart.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM95520060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-12-04
Device Publish Date2016-09-23

Devices Manufactured by SENTREHEART, INC

M95520060 - EndoCATH2023-12-04Large Occlusion Balloon Catheter
M95520060 - EndoCATH2023-12-04 Large Occlusion Balloon Catheter
M95580020 - Tensure2020-05-06 A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascula
M95550010 - SureCUT2020-02-06 A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected sc

Trademark Results [EndoCATH]

Mark Image

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