FDA.reportPublic FDA data

Control 10T Mechanical Thrombectomy System Tubing, Female Suction

Primary DI
B090MT10100F1
Brand
Control 10T Mechanical Thrombectomy System Tubing, Female Suction
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
MT10-100-F
Catalog number
MT10-100-F
Device description
The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.”
Published
2022-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090MT10100F1PackageHIBCC5In Commercial Distribution
B090MT10100F2PackageHIBCC2In Commercial Distribution
B090MT10100F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy tubing set, non-electronicA collection of noninvasive tubing and associated non-powered components (typically connectors, clamps and spikes) designed to conduct fluids from a container (e.g., bag) to a thrombectomy catheter (not included) to assist with the intravascular disruption and removal of clotted blood (i.e., a thrombus or thromboembolus); it does not include invasive devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B090MT2021MorTanMT202 2026-02-10
B090XC2201451XO ConstrainXC2.20-1452026-02-03
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24
10850049994863Syntervention 4008-2032025-09-26
10850049994870Syntervention 4008-3032025-09-26
10850049994887Syntervention 4008-4032025-09-26
10850049994894Syntervention 4008-2052025-09-26
10850049994900Syntervention 4008-3052025-09-26
10850049994917Syntervention 4008-4052025-09-26
10850049994924Syntervention 4008-2072025-09-26
10850049994931Syntervention 4008-3072025-09-26
10850049994948Syntervention 4008-4072025-09-26
10850049994955Syntervention 4008-2092025-09-26
10850049994962Syntervention 4008-3092025-09-26
10850049994979Syntervention4007-4092025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329830397ASPIRATION TUBINGBLACK & BLACK SURGICAL, INC.BYY2026-07-30
00840329837648ASPIRATION TUBINGBLACK & BLACK SURGICAL, INC.BYY2026-07-30
05060212054630Silicone Tube 0.3mm ID x 0.64mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054654Silicone DCR Tube 1.02mm ID x 2.16mm OD x 40mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054661Silicone Tube 1.02mm ID x 2.16mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054678Silicone Tube 1.02mm ID x 2.16mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054685Silicone Tube 1.57mm ID x 3.18mm OD x 250mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054692Silicone Tube 1.57mm ID x 3.18mm OD x 250mm long, two piecesDTR MEDICAL LIMITEDBYY2026-06-10
05060212054715Silicone Tube 1.57mm ID x 3.18mm OD x 450mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054722Silicone Tube 1.57mm ID x 3.18mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054753Silicone Tube 1.98mm ID x 3.18mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054791Silicone Tube 2.65mm ID x 4.88mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054814Silicone Tube 3.2mm ID x 6.4mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054838Silicone Tube 3.2mm ID x 6.4mm OD x 800mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054845Silicone Tube 3.2mm ID x 6.4mm OD 1100mm long- HouseDTR MEDICAL LIMITEDBYY2026-06-10
05060212054876Silicone Tube 4.8mm ID x 7.9mm OD x 150mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054883Silicone Tube 4.8mm ID x 7.9mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054890Silicone Tube 4.8mm ID x 7.9mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054913Silicone Tube 4.8mm ID x 7.9mm OD x 760mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054944Silicone Tube 4.8mm ID x 7.9mm OD x 1350mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054951Silicone Tube 4.8mm ID x 7.9mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054968Silicone Tube 4.8mm ID x 7.9mm OD x 1750mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055002Silicone Tube 5.0mm ID x 8.3mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055026Silicone Tube 5.0mm ID x 8.3mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055095Silicone Tube 6.4mm ID x 9.5mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055118Silicone Tube 6.4mm ID x 9.5mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055125Silicone Tube 6.4mm ID x 9.5mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411983229Sterile Silicone Tube 1.57 ID x 2.41 OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411984066Silicone Tube 3.2mm ID x 6.4mm OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
00848530106300Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BYY2025-07-02