FDA.reportPublic FDA data

Control 10T Mechanical Thrombectomy System Tubing, Female Suction

Primary DI
B090ASP10400
Brand
Control 10T Mechanical Thrombectomy System Tubing, Female Suction
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
ASP-1040
Catalog number
ASP-1040
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
2023-03-28
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

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
B090ASP10401PackageHIBCC5In Commercial Distribution
B090ASP10402PackageHIBCC2In Commercial Distribution
B090ASP10400PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
017535668
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00850068519248SAM Medical IO847W-1P2025-12-09
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10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110900VentiV ScientificP11-090P11-0902025-11-24
B090P11090F0VentiV ScientificP11-090-FP11-090-F2025-11-24
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150028399Liberant™EV3, INCBYY2026-05-07
00628725002224MED-RXCanadian Hospital Specialties LimitedBYY2025-04-25
00628725002231MED-RXCanadian Hospital Specialties LimitedBYY2025-04-25
10192253042894ArgyleCardinal Health 200, LLCBYY2025-02-27
10192253003222ArgyleCardinal Health 200, LLCBYY2024-09-27
50885380194519CARDINAL HEALTHCardinal Health 200, LLCBYY2024-09-18
14026704919410PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
14026704919427PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
14026704919434PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
10840330704264ProCureTwin Med, LLCBYY2024-03-25
10840330704271ProCureTwin Med, LLCBYY2024-03-25
10840330704288ProCureTwin Med, LLCBYY2024-03-25
10840330704295ProCureTwin Med, LLCBYY2024-03-25
10840330704301ProCureTwin Med, LLCBYY2024-03-25
10840330704318ProCureTwin Med, LLCBYY2024-03-25
10840330704325ProCureTwin Med, LLCBYY2024-03-25
10840330704332ProCureTwin Med, LLCBYY2024-03-25
10840330704349ProCureTwin Med, LLCBYY2024-03-25
10850049784891SURGYCOSurgyco LLCBYY2023-10-31
10850049784907SURGYCOSurgyco LLCBYY2023-10-31
10653160360612MEDLINEMEDLINE INDUSTRIES, INC.BYY2023-05-29
B090ASP10390Control 10T Mechanical Thrombectomy FilterZIEN MEDICAL TECHNOLOGIES, INC.BYY2023-03-28
00749756376747DeRoyalDEROYAL INDUSTRIES, INC.BYY2023-02-02
00385640061629SUMMIT MEDICALSummit Medical, Inc.BYY2022-12-19
B090MT100Control 10T Mechanical Thrombectomy FilterZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
B090MT1010030Control 10T Mechanical Thrombectomy System Tubing, 3-PackZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
B090MT10100F0Control 10T Mechanical Thrombectomy System Tubing, Female SuctionZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
20653405015106CONMEDConmed CorporationBYY2022-06-06
10080196035199MedlineMEDLINE INDUSTRIES, INC.BYY2022-04-15
10888277322714MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BYY2022-04-15