Asahi ViE-U Series Dialyzer
K-Number: K162248 · 2017-05-03
ApplicantAsahi Kasei Medical Co., Ltd.
Decision Date2017-05-03
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Asahi ViE-U Series Dialyzer is a medical device manufactured by Asahi Kasei Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-03 under approval number K162248. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Asahi ViE-U Series Dialyzer?
Asahi ViE-U Series Dialyzer is a medical device that received FDA 510(k) clearance on 2017-05-03. It is manufactured by Asahi Kasei Medical Co., Ltd.. The 510(k) number is K162248.
When was Asahi ViE-U Series Dialyzer approved by the FDA?
Asahi ViE-U Series Dialyzer received FDA 510(k) clearance on 2017-05-03, under approval number K162248.
What company makes Asahi ViE-U Series Dialyzer?
Asahi ViE-U Series Dialyzer is manufactured by Asahi Kasei Medical Co., Ltd..
What is the FDA product code for Asahi ViE-U Series Dialyzer?
The FDA product code for Asahi ViE-U Series Dialyzer is KDI.
Other Devices by Asahi Kasei Medical Co., Ltd.
Related Devices (Code: KDI)
K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl
K160881Tablo ConsoleOutset Medical, Inc.
K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC
K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD.
K143482xevonta dialyzerB. Braun Avitum AG
K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.