Control 10T Mechanical Thrombectomy System Tubing, 3-Pack MT10-100-3

GUDID B090MT1010031

The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”

ZIEN MEDICAL TECHNOLOGIES, INC.

Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic Thrombectomy tubing set, non-electronic
Primary Device IDB090MT1010031
NIH Device Record Keya5b38c37-45b8-443e-92eb-e8eebfd36180
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl 10T Mechanical Thrombectomy System Tubing, 3-Pack
Version Model NumberMT10-100-3
Catalog NumberMT10-100-3
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090MT1010030 [Primary]
HIBCCB090MT1010031 [Package]
Contains: B090MT1010030
Package: Shelf Carton [5 Units]
In Commercial Distribution
HIBCCB090MT1010032 [Package]
Package: Shipper [2 Units]
In Commercial Distribution

FDA Product Code

BYYTube, Aspirating, Flexible, Connecting

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-01
Device Publish Date2022-10-24

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

B0902P0130B1 - Knight Microcatheter2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf
B0902P0130S1 - Knight Microcatheter2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf
B090E20130B1 - XO Cath2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in
B090E20130S1 - XO Cath2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in
B090LRKIT1 - Landmark Catheter Introducer Kit2024-05-02 The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA C
B090LRN0591 - LANDMARK2024-01-31 The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control
B090ASP10131 - Control 7F Mechanical Thrombectomy System2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em
B090ASP10211 - Control 11F Mechanical Thrombectomy System2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.