FDA.reportPublic FDA data

SUCTION CATHETER WITH VACUUM CONTROL 18 600

Primary DI
04816415501089
Brand
SUCTION CATHETER WITH VACUUM CONTROL 18 600
Company
ASSOMEDIKA, OOO
Model
1001 060 218
Device description
A 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.
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCDConnector, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04816415501089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04816415501089048164155010894816415501089

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.

Regulatory Flags#

DUNS number
683522555
Device count
1
Premarket exempt
true
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
04816415501379LARYNGEAL MASK Single Use Size 2N/A2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3N/A2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5N/A2026-05-27
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmN/A2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmN/A2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmN/A2026-05-27
04816415501430BREATHING BAG single use 500N/A2026-05-27
04816415501447BREATHING BAG single use 1000N/A2026-05-27
04816415501454BREATHING BAG single use 2000N/A2026-05-27
04816415501461BREATHING BAG single use 3000N/A2026-05-27
04816415501478BREATHING BAG reusable 500N/A2026-05-27
04816415501485BREATHING BAG reusable 1000N/A2026-05-27
04816415501492BREATHING BAG reusable 2000N/A2026-05-27
04816415501508BREATHING BAG reusable 3000N/A2026-05-27
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEN/A2026-05-26
04816415501263FOOT URINE COLLECTORN/A2026-05-26
04816415501270BEDSIDE URINE COLLECTORN/A2026-05-26
04816415501287BREATHING MASK Single Use Size 0N/A2026-05-26
04816415501294BREATHING MASK Single Use Size 3N/A2026-05-26
04816415501300BREATHING MASK Single Use Size 6N/A2026-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253042832ArgyleCardinal Health 200, LLCGCD2025-02-27
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10192253042863ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042870ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042887ArgyleCardinal Health 200, LLCGCD2025-02-27
14026704933126PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933133PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933140PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933157PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
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