FDA.reportPublic FDA data

Neuroguard IEP® System

Primary DI
00851616007644
Brand
Neuroguard IEP® System
Company
Contego Medical, Inc.
Model
NG-NV-6-30
Catalog number
NG-NV-6-30
Device description
The Neuroguard IEP System consists of three main components:• A self-expanding nitinol stent• A delivery catheter which includes a post-dilation balloon and activation handle• Embolic protection filter that is integrated at the distal end of the delivery system
Published
2025-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIMStent, Carotid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIMStent, CarotidUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240009000Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.2024-10-11NIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851616007644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851616007644008516160076448516160076440851616007644

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-800-708-7271info@contegomedical.com

Regulatory Flags#

DUNS number
048268128
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851616007668Excipio® LV PRIME Thrombectomy DeviceEXC-1607-150EXC-1607-1502025-07-25
00851616007620Neuroguard IEP® SystemNG-NV-7-40NG-NV-7-402025-01-21
00851616007637Neuroguard IEP® SystemNG-NV-7-30NG-NV-7-302025-01-21
00851616007651Neuroguard IEP® SystemNG-NV-6-40NG-NV-6-402025-01-21
00851616007583Neuroguard IEP® SystemNG-0630-140-2NG-0630-140-22024-10-23
00851616007590Neuroguard IEP® SystemNG-0640-140-2NG-0640-140-22024-10-23
00851616007606Neuroguard IEP® SystemNG-0730-140-2NG-0730-140-22024-10-23
00851616007613Neuroguard IEP® SystemNG-0740-140-2NG-0740-140-22024-10-23
00851616007545Excipio LV EXC-2510-125EXC-2510-1252023-09-23
00851616007149Vanguard 6200x135V1-6200-135-012023-09-05
00851616007156Vanguard 5080x135V1-5080-135-012023-09-05
00851616007293Paladin5.5x30PD-5530-140-22023-09-05
00851616007385Vanguard 6080x135V1-6080-135-012023-09-05
00851616007453Vanguard 5200x135V1-5200-135-012023-09-05
00851616007460Vanguard 6120x135V1-6120-135-012023-09-05
00851616007477Paladin5.5.x20PD-5520-140-22023-09-05
00851616007491Excipio SVEXC-0940-165EXC-0940-1652023-09-05
00851616007538Vanguard 5120x135V1-5120-135-012023-09-05
00851616007002Paladin5x30PD-5030-140-22023-09-05
00851616007309Paladin5x20PD-5020-140-22023-09-05

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Primary DI, Brand, Company table
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00811425020937Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
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00811425024713Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
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