Asahi Kasei Medical Co., Ltd.
Chiyoda-ku, JP
ASAHI KASEI MEDICAL CO., LTD. appears in FDA device records in Chiyoda-ku, JP. FDA records list 5 510(k) clearances between and , 17 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Asahi Kasei Medical Co., Ltd. between 2005 and 2017. The busiest year on record is 2005, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162248 | Asahi ViE-U Series Dialyzer | KDI | Substantially Equivalent | |
| K153344 | Asahi REXEED-S Series Dialyzer | KDI | Substantially Equivalent | |
| K121409 | ASAHI REXEED-SX/LX SERIES DIALYZER | KDI | Substantially Equivalent | |
| K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX | KDI | Substantially Equivalent | |
| K051187 | REXEED SERIES DIALYZERS | KDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009960884 | 3009960884 | ASAHI KASEI MEDICAL CO., LTD. | 1-1-2 Yurakucho, Chiyoda-ku Tokyo 100-0006 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain