Duns Number:272983094
Device Description: The device is an Optional Vena Cava Filter - Jugular Kit with Hook. It consists of a nine The device is an Optional Vena Cava Filter - Jugular Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.
Catalog Number
-
Brand Name
ALN Optional Vena Cava Filter - Jugular Approach with Hook
Version/Model Number
FJ.HOOK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K163699
Product Code
DTK
Product Code Name
Filter, Intravascular, Cardiovascular
Public Device Record Key
9bc3a6f1-c301-4c1a-a6cf-5cf9e646de64
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 26, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |