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FDA 510(k)

nextaro® va, 15mm, 5µm

K-Number: K241976 · 2024-09-06

ApplicantSfm Medical Devices GmbH
Decision Date2024-09-06
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

nextaro® va, 15mm, 5µm is the device name listed in this FDA 510(k) record. The listed applicant is Sfm Medical Devices GmbH. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K241976. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the nextaro® va, 15mm, 5µm?

nextaro® va, 15mm, 5µm is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Sfm Medical Devices GmbH. The 510(k) number is K241976.

When did nextaro® va, 15mm, 5µm receive FDA 510(k) clearance?

nextaro® va, 15mm, 5µm received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241976.

Who is the listed applicant for nextaro® va, 15mm, 5µm?

The FDA 510(k) record lists Sfm Medical Devices GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for nextaro® va, 15mm, 5µm?

The FDA product code for nextaro® va, 15mm, 5µm is LHI.

Other records listing Sfm Medical Devices GmbH 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.

K240748nextaro® v, 20/20K183187nextaro Transfer System, nextaro va

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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