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FDA 510(k)

BAIXIN INTRAVASCULAR ADMINISTRATION SET

K-Number: K083687 · 2009-06-11

ApplicantAnhui Kangda Medical Products Co., Ltd.
Decision Date2009-06-11
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAIXIN INTRAVASCULAR ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Kangda Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2009-06-11 under 510(k) number K083687. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAIXIN INTRAVASCULAR ADMINISTRATION SET?

BAIXIN INTRAVASCULAR ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 2009-06-11. The listed applicant is Anhui Kangda Medical Products Co., Ltd.. The 510(k) number is K083687.

When did BAIXIN INTRAVASCULAR ADMINISTRATION SET receive FDA 510(k) clearance?

BAIXIN INTRAVASCULAR ADMINISTRATION SET received FDA 510(k) clearance on 2009-06-11, under 510(k) number K083687.

Who is the listed applicant for BAIXIN INTRAVASCULAR ADMINISTRATION SET?

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

What is the FDA product code for BAIXIN INTRAVASCULAR ADMINISTRATION SET?

The FDA product code for BAIXIN INTRAVASCULAR ADMINISTRATION SET is FPA.

Related Clinical Trials

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Other records listing Anhui Kangda Medical Products 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.

K083686BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

Official Source

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