ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
FDA 510(k) clearance K082515 · decided 2008-10-03
Clearance details
- K-number
- K082515
- Device name
- ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
- Applicant
- Asahi Kasei Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-02
- Decision date
- 2008-10-03
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter recall (Z-2418-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
| Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter recall (Z-2419-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
| Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter recall (Z-2420-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
| Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter recall (Z-2421-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
| Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter recall (Z-2422-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
| Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter recall (Z-2423-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
| Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter recall (Z-2424-2012) | Asahi Kasei Medical Co., Ltd., Okatomi Plant | 2012-09-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Plasmaflo OP-05 W(A) (P820033/S019) | Asahi Kasei Medical Co., Ltd. | 2026-04-09 |
| Plasmaflo OP-05W(A) (P820033/S017) | Asahi Kasei Medical Co., Ltd. | 2025-09-30 |
| Plasmaflo OP-05W(A) (P820033/S018) | Asahi Kasei Medical Co., Ltd. | 2024-06-18 |
| Plasmaflo OP-05W(A) (P820033/S016) | Asahi Kasei Medical Co., Ltd. | 2023-01-05 |
| Plasmaflo OP-05W (A) (P820033/S015) | Asahi Kasei Medical Co., Ltd. | 2022-02-08 |
| Plasmaflo OP-05W(A) (P820033/S014) | Asahi Kasei Medical Co., Ltd. | 2021-03-03 |
| Plasmaflo OP-05W(A) (P820033/S013) | Asahi Kasei Medical Co., Ltd. | 2020-10-22 |
| Plasmaflo OP-05W(A) (P820033/S012) | Asahi Kasei Medical Co., Ltd. | 2018-02-15 |