Product code MDP
- Device name
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- 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 |
|---|---|---|---|
| P820033S019 | Plasmaflo OP-05 W(A) | Asahi Kasei Medical Co., Ltd. | 2026-04-09 |
| P830063S030 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2026-03-13 |
| P830063S031 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2025-12-23 |
| P820033S017 | Plasmaflo OP-05W(A) | Asahi Kasei Medical Co., Ltd. | 2025-09-30 |
| P830063S029 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2024-12-06 |
| P830063S028 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2024-10-24 |
| P820033S018 | Plasmaflo™ OP-05W(A) | Asahi Kasei Medical Co., Ltd. | 2024-06-18 |
| P830063S027 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2024-01-10 |
| P830063S026 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2023-10-27 |
| P830063S025 | Prismaflex TPE2000 | Vantive US Healthcare, LLC | 2023-03-29 |
| P820033S016 | Plasmaflo OP-05W(A) | Asahi Kasei Medical Co., Ltd. | 2023-01-05 |
| P830063S024 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2022-11-08 |
| P830063S023 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2022-04-07 |
| P830063S022 | PRISMAFLEX TPE2000 SET | Vantive US Healthcare, LLC | 2022-03-31 |
| P820033S015 | Plasmaflo OP-05W (A) | Asahi Kasei Medical Co., Ltd. | 2022-02-08 |
| P830063S020 | Gambro Prismaflex TPE 2000 Set | Vantive US Healthcare, LLC | 2022-01-27 |
| P830063S018 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2021-07-16 |
| P830063S019 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2021-06-24 |
| P820033S014 | Plasmaflo OP-05W(A) | Asahi Kasei Medical Co., Ltd. | 2021-03-03 |
| P830063S013 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2021-02-12 |
| P820033S013 | Plasmaflo OP-05W(A) | Asahi Kasei Medical Co., Ltd. | 2020-10-22 |
| P830063S017 | Gambro Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2020-08-27 |
| P830063S016 | PRISMAFLEX TPE 2000 Set | Vantive US Healthcare, LLC | 2020-05-23 |
| P830063S015 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2020-03-25 |
| P830063S014 | PRISMAFLEX TPE2000 | Vantive US Healthcare, LLC | 2019-12-11 |
| P830063S012 | Prismaflex TPE2000 Set | Vantive US Healthcare, LLC | 2019-09-18 |
| P820033S012 | Plasmaflo OP-05W(A) | Asahi Kasei Medical Co., Ltd. | 2018-02-15 |
| P820033S011 | Plasmaflo | Asahi Kasei Medical Co., Ltd. | 2018-01-17 |
| P830063S010 | PRISMAFLEX TPE 2000 Set | Vantive US Healthcare, LLC | 2017-11-21 |
| P830063S009 | PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N | Vantive US Healthcare, LLC | 2016-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00880304828308 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830387 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830370 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830356 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830349 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830325 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830318 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830301 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830288 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830271 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830264 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830257 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830240 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828339 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828315 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827455 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828292 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828278 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828254 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828223 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828216 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828209 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828193 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828186 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827530 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827523 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827516 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827486 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827479 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827462 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |