Excipio SV EXC-0940-165

GUDID 00851616007491

The Excipio SV Thrombectomy Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

Contego Medical, Inc.

Thrombectomy suction catheter
Primary Device ID00851616007491
NIH Device Record Key6b02939b-adfe-4ebd-baf8-dd2f56fb2d7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcipio SV
Version Model NumberEXC-0940-165
Catalog NumberEXC-0940-165
Company DUNS048268128
Company NameContego Medical, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com
Phone+1-919-459-7250
Emailinfo@contegomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851616007491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-13
Device Publish Date2023-09-05

Devices Manufactured by Contego Medical, Inc.

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00851616007613 - Neuroguard IEP® System2024-10-31 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
00851616007545 - Excipio LV 2023-10-02 The Excipio LV Thrombectomy Device is indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels
00851616007149 - Vanguard 2023-09-13 The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous translum
00851616007156 - Vanguard 2023-09-13 The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous translum
00851616007293 - Paladin2023-09-13 The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angi

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