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FDA 510(k)

DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS

K-Number: K102833 · 2011-11-18

ApplicantFoshan Nanhai Bai HE Medical Technology Co., Ltd.
Decision Date2011-11-18
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Bai HE Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K102833. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS?

DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Foshan Nanhai Bai HE Medical Technology Co., Ltd.. The 510(k) number is K102833.

When did DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS receive FDA 510(k) clearance?

DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS received FDA 510(k) clearance on 2011-11-18, under 510(k) number K102833.

Who is the listed applicant for DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS?

The FDA 510(k) record lists Foshan Nanhai Bai HE Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS?

The FDA product code for DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS is MPB.

Related Clinical Trials

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.

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Other records listing Foshan Nanhai Bai HE Medical Technology Co., Ltd. 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.

K070451ABLE CENTRAL VENOUS CATHETER

Related Devices (Code: MPB)

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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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