Exeltra High Flux Dialyzer, Models 150 & 170
FDA 510(k) K030974 · Baxter Healthcare Corp
510(k) numberK030974
Submission
- Device name
- Exeltra High Flux Dialyzer, Models 150 & 170
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- March 28, 2003
- Decision date
- April 25, 2003
- 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 Exeltra High Flux Dialyzer, Models 150 & 170 cleared by the FDA?
Exeltra High Flux Dialyzer, Models 150 & 170 (K030974) received a 510(k) decision of Substantially Equivalent on April 25, 2003, 28 days after the submission was received.
What is the product code of K030974?
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.