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Asahi REXEED-S Series Dialyzer
FDA 510(k)Class II (US FDA 510(k))
510(k) K153344
Identifiers
- 510(k) Number
- K153344 FDA 510(k)
- FDA Product Code
- KDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Asahi REXEED-S Series Dialyzer by Asahi Kasei Medical Co., Ltd. — Class II — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (0 countries)
Regulatory Authorizations
No authorizations listed.
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Manufacturer
- Manufacturer
- Asahi Kasei Medical Co., Ltd.
Sources (1)
- FDA 510(k) K153344 24 fields · synced Oct 7, 2026