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FDA 510(k)

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

K-Number: K201809 · 2021-03-10

ApplicantBaxter Healthcare Corportation
Decision Date2021-03-10
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is a medical device manufactured by Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2021-03-10 under approval number K201809. 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 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Baxter Healthcare Corportation. The 510(k) number is K201809.

When was AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory approved by the FDA?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory received FDA 510(k) clearance on 2021-03-10, under approval number K201809.

What company makes AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is manufactured by Baxter Healthcare Corportation.

What is the FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

The FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is KDI.

Related Clinical Trials

NCT07604662 Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial NOT_YET_RECRUITING NCT06832696 Assessment of a Wearable Ultrafiltration Device NOT_YET_RECRUITING

Other Devices by Baxter Healthcare Corportation

K193137EASYGRIP FLO-41 Precision MIS Delivery System K233441The Vest APX System (PVAPX1)

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.

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