Plasmaflo OP-05W (A)
FDA premarket approval P820033/S015 · decided 2022-02-08
Approval details
- PMA number
- P820033
- Supplement
- S015
- 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
- 2022-01-11
- Decision date
- 2022-02-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Tokyo
- Statement
- Use of new equipment for the EVOH coating process, and the hollow fiber (HF) drying process to increase the hollow fiber drying capacity.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |