Edwards Aquarius System, Model GE-F098-00

Q: What is the product code of K090682?

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.

FDA 510(k) K090682 · Edwards Lifesciences Services GmbH

Substantially Equivalent

510(k) numberK090682

Submission

Device name: Edwards Aquarius System, Model GE-F098-00
Applicant: Edwards Lifesciences Services GmbH
Welwyn Garden City, GB
Received: March 16, 2009
Decision date: November 19, 2009
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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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More from Fresenius Medical Care Renal Therapies Group, LLC

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K070320	Edwards Aquarius Hemofiltration System, Model Abm 01KDI · Traditional	06/07/2007SE
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Questions and answers

When was Edwards Aquarius System, Model GE-F098-00 cleared by the FDA?

Edwards Aquarius System, Model GE-F098-00 (K090682) received a 510(k) decision of Substantially Equivalent on November 19, 2009, 248 days after the submission was received.

What is the product code of K090682?

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.