Decision Date2021-12-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Blood Collection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Vacutest Kima Srl. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K200932. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Blood Collection Needles?
Blood Collection Needles is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Vacutest Kima Srl. The 510(k) number is K200932.
When did Blood Collection Needles receive FDA 510(k) clearance?
Blood Collection Needles received FDA 510(k) clearance on 2021-12-14, under 510(k) number K200932.
Who is the listed applicant for Blood Collection Needles?
The FDA 510(k) record lists Vacutest Kima Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blood Collection Needles?
The FDA product code for Blood Collection Needles is FMI.
Related Devices (Code: FMI)
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.
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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.