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FDA 510(k)

BLOOD TUBING SETS (STERILE FLUID PATH)

K-Number: K080807 · 2008-07-18

ApplicantNxstage Medical, Inc.
Decision Date2008-07-18
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLOOD TUBING SETS (STERILE FLUID PATH) is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K080807. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD TUBING SETS (STERILE FLUID PATH)?

BLOOD TUBING SETS (STERILE FLUID PATH) is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K080807.

When did BLOOD TUBING SETS (STERILE FLUID PATH) receive FDA 510(k) clearance?

BLOOD TUBING SETS (STERILE FLUID PATH) received FDA 510(k) clearance on 2008-07-18, under 510(k) number K080807.

Who is the listed applicant for BLOOD TUBING SETS (STERILE FLUID PATH)?

The FDA 510(k) record lists Nxstage Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD TUBING SETS (STERILE FLUID PATH)?

The FDA product code for BLOOD TUBING SETS (STERILE FLUID PATH) is FJK.

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Other records listing Nxstage Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow SolutionK230632VersiHD with GuideMe softwareK183158NxStage Cartridge Express with SpeedswapK181991NxStage Connected Health SystemK171331NxStage System One

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Related Devices (Code: FJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset 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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