Duns Number:896415242
Device Description: The Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Embolism via 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.
Catalog Number
NM60-16-28
Brand Name
Sentry IVC Filter
Version/Model Number
146155-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 10, 2022
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTK
Product Code Name
Filter, Intravascular, Cardiovascular
Public Device Record Key
41f8a47f-e5d1-4f41-a95a-f27d075a4e8b
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 27, 2018
Package DI Number
05391529380076
Quantity per Package
5
Contains DI Package
05391529380069
Package Discontinue Date
October 10, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |