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FDA 510(k)

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

K-Number: K112628 · 2012-09-28

ApplicantNipro Medical Corporation
Decision Date2012-09-28
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K112628. 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 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET?

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Nipro Medical Corporation. The 510(k) number is K112628.

When did NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET receive FDA 510(k) clearance?

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET received FDA 510(k) clearance on 2012-09-28, under 510(k) number K112628.

Who is the listed applicant for NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET?

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

What is the FDA product code for NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET?

The FDA product code for NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET is FJK.

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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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