Duns Number:690535406
Device Description: Indications for FH:The LIPOSORBER® LA-15 System is indicated for use in performing low den Indications for FH:The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.Indications for FSGS:The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
Catalog Number
N/A
Brand Name
LIPOSORBER
Version/Model Number
LA-15
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
P910018,H120005,P910018,P910018,H120005,P910018,P910018,H120005,P910018
Product Code
MMY
Product Code Name
Lipoprotein, Low Density, Removal
Public Device Record Key
097fa2bd-0bf9-4ac6-bf30-45a06efc9fb4
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 26, 2014
Package DI Number
24993478010117
Quantity per Package
6
Contains DI Package
14993478010110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carrier Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1041 |
| U | Unclassified | 1 |