FDA.reportPublic FDA data

Excipio SV

Primary DI
00851616007491
Brand
Excipio SV
Company
Contego Medical, Inc.
Model
EXC-0940-165
Catalog number
EXC-0940-165
Device description
The Excipio SV Thrombectomy Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221204000Excipio SV Thrombectomy DeviceContego Medical, Inc.2022-06-23QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851616007491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851616007491008516160074918516160074910851616007491

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-919-459-7250info@contegomedical.com
+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
00851616007644Neuroguard IEP® SystemNG-NV-6-30NG-NV-6-302025-01-21
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
00851616007538Vanguard 5120x135V1-5120-135-012023-09-05
00851616007002Paladin5x30PD-5030-140-22023-09-05
00851616007309Paladin5x20PD-5020-140-22023-09-05

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