DEVICE: Control 11F Mechanical Thrombectomy System (B090ASP10360)
Device Identifier (DI) Information
Control 11F Mechanical Thrombectomy System
ASP-1036
In Commercial Distribution
ASP-1036
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1036
In Commercial Distribution
ASP-1036
ZIEN MEDICAL TECHNOLOGIES, INC.
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47017 | General-purpose syringe, single-use |
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
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Active | false |
58173 | Thrombectomy suction catheter |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QEZ | Aspiration Thrombectomy Catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Working Length: 60 Centimeter |
Catheter Gauge: 11 French |
Device Record Status
6d7a6f2a-aa4f-43b8-a120-4ae79963683f
May 11, 2023
1
May 03, 2023
May 11, 2023
1
May 03, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B090ASP10361 | 1 | B090ASP10360 | In Commercial Distribution | Shelf Carton | |
B090ASP10362 | 9 | B090ASP10361 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined