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FDA 510(k)

DRAGON HEART I.V. SET

K-Number: K043235 · 2005-03-08

ApplicantDragon Heart Medical Devices Co., Ltd.
Decision Date2005-03-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRAGON HEART I.V. SET is the device name listed in this FDA 510(k) record. The listed applicant is Dragon Heart Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2005-03-08 under 510(k) number K043235. 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 DRAGON HEART I.V. SET?

DRAGON HEART I.V. SET is a medical device that received FDA 510(k) clearance on 2005-03-08. The listed applicant is Dragon Heart Medical Devices Co., Ltd.. The 510(k) number is K043235.

When did DRAGON HEART I.V. SET receive FDA 510(k) clearance?

DRAGON HEART I.V. SET received FDA 510(k) clearance on 2005-03-08, under 510(k) number K043235.

Who is the listed applicant for DRAGON HEART I.V. SET?

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

What is the FDA product code for DRAGON HEART I.V. SET?

The FDA product code for DRAGON HEART I.V. SET is FPA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dragon Heart Medical Devices 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.

K042547DRAGON HEART PISTON SYRINGE

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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