510(k) K153344
K153344 is an FDA 510(k) premarket notification submitted by Asahi Kasei Medical Co., Ltd. for the device "Asahi REXEED-S Series Dialyzer". The FDA issued a decision of Substantially Equivalent on Dec 17, 2015. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Asahi Kasei Medical Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2015
- Date Received
- Nov 19, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type
- 510(k)