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FDA 510(k)

BD Alaris™ Pump Epidural Infusion Set

K-Number: K221319 · 2023-07-21

ApplicantCare Fusion
Decision Date2023-07-21
Product CodePWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Alaris™ Pump Epidural Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K221319. The device is classified under product code PWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Alaris™ Pump Epidural Infusion Set?

BD Alaris™ Pump Epidural Infusion Set is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Care Fusion. The 510(k) number is K221319.

When did BD Alaris™ Pump Epidural Infusion Set receive FDA 510(k) clearance?

BD Alaris™ Pump Epidural Infusion Set received FDA 510(k) clearance on 2023-07-21, under 510(k) number K221319.

Who is the listed applicant for BD Alaris™ Pump Epidural Infusion Set?

The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Alaris™ Pump Epidural Infusion Set?

The FDA product code for BD Alaris™ Pump Epidural Infusion Set is PWH.

Related Clinical Trials

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NCT01856166PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in NulliparousCOMPLETED

Other records listing Care Fusion 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.

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceK231888BD Texium™ Needle-Free SyringeK221327BD Alaris™ Pump Infusion SetsK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free ConnectorK223076BD Texium™ Closed Male Luer

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Related Devices (Code: PWH)

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.

K211649PCEA Syringe SetBaxter Healthcare CorporationK172592CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc.K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc.

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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