Clirans E-Series Dialyzer
FDA 510(k) K013550 · Terumo Medical Corp.
510(k) numberK013550
Submission
- Device name
- Clirans E-Series Dialyzer
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- October 24, 2001
- Decision date
- November 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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Questions and answers
When was Clirans E-Series Dialyzer cleared by the FDA?
Clirans E-Series Dialyzer (K013550) received a 510(k) decision of Substantially Equivalent on November 20, 2001, 27 days after the submission was received.
What is the product code of K013550?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.