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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 a medical device manufactured by Care Fusion. It received FDA 510(k) clearance on 2023-07-21 under approval 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. It is manufactured by Care Fusion. The 510(k) number is K221319.

When was BD Alaris™ Pump Epidural Infusion Set approved by the FDA?

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

What company makes BD Alaris™ Pump Epidural Infusion Set?

BD Alaris™ Pump Epidural Infusion Set is manufactured by Care Fusion.

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.

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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.