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FDA 510(k)

V-HEPES PLUS

K-Number: K213293 · 2022-09-14

ApplicantVitromed Langenfeld
Decision Date2022-09-14
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

V-HEPES PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Vitromed Langenfeld. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K213293. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-HEPES PLUS?

V-HEPES PLUS is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Vitromed Langenfeld. The 510(k) number is K213293.

When did V-HEPES PLUS receive FDA 510(k) clearance?

V-HEPES PLUS received FDA 510(k) clearance on 2022-09-14, under 510(k) number K213293.

Who is the listed applicant for V-HEPES PLUS?

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

What is the FDA product code for V-HEPES PLUS?

The FDA product code for V-HEPES PLUS is MQL.

Related Devices (Code: MQL)

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.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

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.

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