SteadiSet Infusion Set
K-Number: K242692 · 2025-05-09
ApplicantCapillary Biomedical, LLC
Decision Date2025-05-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SteadiSet Infusion Set is a medical device manufactured by Capillary Biomedical, LLC. It received FDA 510(k) clearance on 2025-05-09 under approval number K242692. 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 SteadiSet Infusion Set?
SteadiSet Infusion Set is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Capillary Biomedical, LLC. The 510(k) number is K242692.
When was SteadiSet Infusion Set approved by the FDA?
SteadiSet Infusion Set received FDA 510(k) clearance on 2025-05-09, under approval number K242692.
What company makes SteadiSet Infusion Set?
SteadiSet Infusion Set is manufactured by Capillary Biomedical, LLC.
What is the FDA product code for SteadiSet Infusion Set?
The FDA product code for SteadiSet Infusion Set is FPA.
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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.