Product code MMY
- Device name
- Lipoprotein, Low Density, Removal
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P910018S041 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | 2026-03-30 |
| P910018S037 | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). | Kaneka Pharma America Corp. | 2025-03-05 |
| P910018S039 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | 2025-01-24 |
| P910018S036 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | 2025-01-15 |
| P910018S040 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2024-09-26 |
| P910018S038 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | 2024-08-27 |
| P910018S035 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2023-03-01 |
| P910018S034 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2022-06-30 |
| P910018S033 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2022-04-29 |
| P910018S032 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2022-01-14 |
| P910018S029 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2021-08-06 |
| P910018S031 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2021-07-28 |
| P910018S030 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | 2021-04-29 |
| P910018S028 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2020-12-22 |
| P910018S027 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2020-04-21 |
| P940016S027 | H.E.L.P. Futura Apheresis System | B. Braun Avitum AG | 2019-06-07 |
| P940016S026 | Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System | B. Braun Avitum AG | 2019-05-22 |
| P910018S026 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2019-05-22 |
| P910018S023 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2019-03-28 |
| P940016S025 | H.E.L.P. Futura Apheresis System | B. Braun Avitum AG | 2018-06-28 |
| P910018S025 | Liposorber LA-15 System | Kaneka Pharma America Corp. | 2018-04-12 |
| P910018S024 | LIPOSORBER LA-15 System | Kaneka Pharma America Corp. | 2018-03-26 |
| P940016S024 | Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System | B. Braun Avitum AG | 2017-11-07 |
| P940016S023 | Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System | B. Braun Avitum AG | 2017-07-06 |
| P910018S022 | LIPOSORBER(R) LA-15 SYSTEM | Kaneka Pharma America Corp. | 2017-05-23 |
| P940016S022 | H.E.L.P. Futura Apheresis System | B. Braun Avitum AG | 2016-11-15 |
| P910018S021 | LIPOSORBER(R) LA-15 SYSTEM | Kaneka Pharma America Corp. | 2016-10-14 |
| P910018S020 | LIPOSORBER® LA-15 SYSTEM | Kaneka Pharma America Corp. | 2016-09-23 |
| P940016S021 | HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM | B. Braun Avitum AG | 2016-09-09 |
| P910018S019 | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). | Kaneka Pharma America Corp. | 2016-04-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 18855036020688 | TUBING SYSTEM FOR PLASMAPHERESIS | KANEKA PHARMA AMERICA LLC | 2018-08-21 |
| 04046963711139 | B.BRAUN | B.Braun Avitum AG | 2017-01-20 |
| 04046963845773 | B.BRAUN | B.Braun Avitum AG | 2017-01-20 |
| 04046964290152 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964290145 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964290138 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963711184 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964231834 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964290169 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964133534 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963847418 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963845780 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963845766 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963711177 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963711160 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963711153 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964319860 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046964249679 | B.BRAUN | B.Braun Avitum AG | 2017-01-18 |
| 04046963845797 | B.BRAUN | B.Braun Avitum AG | 2017-01-17 |
| 04046964695865 | H.E.L.P.® | B.Braun Avitum AG | 2016-03-09 |
| 04046964696770 | H.E.L.P.® | B.Braun Avitum AG | 2016-03-09 |
| 04046964699467 | H.E.L.P.® | B.Braun Avitum AG | 2016-03-09 |
| 04046964156731 | H.E.L.P.® | B.Braun Avitum AG | 2016-03-09 |
| 18855036012850 | TUBING SYSTEM FOR PLASMAPHERESIS | KANEKA PHARMA AMERICA LLC | 2015-02-09 |
| 04537693900639 | SULFLUX | KANEKA PHARMA AMERICA LLC | 2014-12-17 |
| 14993478010110 | LIPOSORBER | KANEKA CORPORATION | 2014-09-26 |
| 04987671040374 | APHERESIS MACHINE | KANEKA PHARMA AMERICA LLC | 2014-09-25 |
| 04046964337017 | B.BRAUN | B.Braun Avitum AG | 2014-09-15 |