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FDA 510(k)

Sterile Single-use Infusion Set

K-Number: K163160 · 2017-04-20

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.
Decision Date2017-04-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Single-use Infusion Set is a medical device manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-04-20 under approval number K163160. 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 Sterile Single-use Infusion Set?

Sterile Single-use Infusion Set is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163160.

When was Sterile Single-use Infusion Set approved by the FDA?

Sterile Single-use Infusion Set received FDA 510(k) clearance on 2017-04-20, under approval number K163160.

What company makes Sterile Single-use Infusion Set?

Sterile Single-use Infusion Set is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd..

What is the FDA product code for Sterile Single-use Infusion Set?

The FDA product code for Sterile Single-use Infusion Set is FPA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT06729827 Predictive Hemodynamic Monitoring During Elective Cesarean Section COMPLETED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Jiangxi Hongda Medical Equipment Group , Ltd.

K163162Sterile Hypodermic Safety Syringes for Single Use K163161Sterile Single-use Syringe with Needle K211753Sterile Syringe With Safety Needle K210578Medical Nitrile Examination Gloves (Power free, Blue) K210821Medical PVC Examination Gloves

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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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