DEVICE: Sentry IVC Filter (05391529380069)
Device Identifier (DI) Information
Sentry IVC Filter
146155-01
Not in Commercial Distribution
NM60-16-28
NOVATE MEDICAL LIMITED
146155-01
Not in Commercial Distribution
NM60-16-28
NOVATE MEDICAL LIMITED
The Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Embolism via percutaneous placement in the inferior vena cava in patients at transient risk of PE, in the following situations:
• Pulmonary thromboembolism when anticoagulants are contraindicated.
• Failure of anticoagulant therapy in thromboembolic diseases.
• Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
44864 | Vena cava filter, temporary/permanent |
A vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DTK | Filter, Intravascular, Cardiovascular |
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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No Device Sizes |
Device Record Status
41f8a47f-e5d1-4f41-a95a-f27d075a4e8b
October 11, 2022
4
September 27, 2018
October 11, 2022
4
September 27, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05391529380076 | 5 | 05391529380069 | 2022-10-10 | Not in Commercial Distribution |
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