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FDA 510(k)

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

K-Number: K242155 · 2025-05-15

ApplicantNIKKISO CO., LTD.
Decision Date2025-05-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is a medical device manufactured by NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2025-05-15 under approval number K242155. 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 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)?

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by NIKKISO CO., LTD.. The 510(k) number is K242155.

When was DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) approved by the FDA?

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) received FDA 510(k) clearance on 2025-05-15, under approval number K242155.

What company makes DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)?

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is manufactured by NIKKISO CO., LTD..

What is the FDA product code for DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)?

The FDA product code for DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is KDI.

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Other Devices by NIKKISO CO., LTD.

K152938DBB-06 Hemodialysis Delivery System K231589Blood Tubing Lines for Hemodialysis AV06C-E K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

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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