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FDA 510(k)

I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT

K-Number: K083429 · 2009-08-07

ApplicantWeihai Jierui Medical Products Co., Ltd.
Decision Date2009-08-07
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Jierui Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K083429. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT?

I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Weihai Jierui Medical Products Co., Ltd.. The 510(k) number is K083429.

When did I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT receive FDA 510(k) clearance?

I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT received FDA 510(k) clearance on 2009-08-07, under 510(k) number K083429.

Who is the listed applicant for I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT?

The FDA 510(k) record lists Weihai Jierui Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT?

The FDA product code for I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT is FOZ.

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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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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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