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FDA 510(k)

DBB-06 Hemodialysis Delivery System

K-Number: K152938 · 2016-03-18

ApplicantNIKKISO CO., LTD.
Decision Date2016-03-18
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DBB-06 Hemodialysis Delivery System is a medical device manufactured by NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2016-03-18 under approval number K152938. 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 Hemodialysis Delivery System?

DBB-06 Hemodialysis Delivery System is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by NIKKISO CO., LTD.. The 510(k) number is K152938.

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

DBB-06 Hemodialysis Delivery System received FDA 510(k) clearance on 2016-03-18, under approval number K152938.

What company makes DBB-06 Hemodialysis Delivery System?

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

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

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

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Other Devices by NIKKISO CO., LTD.

K231589Blood Tubing Lines for Hemodialysis AV06C-E K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) 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 K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc. K171331NxStage System OneNxstage 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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