Plasmaflo OP-05W(A)
FDA premarket approval P820033/S012 · decided 2018-02-15
Approval details
- PMA number
- P820033
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Plasmaflo OP-05W(A)
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Asahi Kasei Medical Co., Ltd.
- Date received
- 2018-01-19
- Decision date
- 2018-02-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Tokyo
- Statement
- Change in the bioburden recovery procedure for the Plasmaflo OP-05W(A).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Asahi ViE-U Series Dialyzer (K162248) | Asahi Kasei Medical Co., Ltd. | 2017-05-03 |
| Asahi REXEED-S Series Dialyzer (K153344) | Asahi Kasei Medical Co., Ltd. | 2015-12-17 |
| ASAHI REXEED-SX/LX SERIES DIALYZER (K121409) | Asahi Kasei Medical Co., Ltd. | 2013-02-06 |
| ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX (K082515) | Asahi Kasei Medical Co., Ltd. | 2008-10-03 |
| REXEED SERIES DIALYZERS (K051187) | Asahi Kasei Medical Co., Ltd. | 2005-06-08 |