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FDA 510(k)

GRI-FILL PERISTALTIC SET

K-Number: K162216 · 2017-10-19

ApplicantLaboratorios Grifols, S.A.
Decision Date2017-10-19
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GRI-FILL PERISTALTIC SET is the device name listed in this FDA 510(k) record. The listed applicant is Laboratorios Grifols, S.A.. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K162216. 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 GRI-FILL PERISTALTIC SET?

GRI-FILL PERISTALTIC SET is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Laboratorios Grifols, S.A.. The 510(k) number is K162216.

When did GRI-FILL PERISTALTIC SET receive FDA 510(k) clearance?

GRI-FILL PERISTALTIC SET received FDA 510(k) clearance on 2017-10-19, under 510(k) number K162216.

Who is the listed applicant for GRI-FILL PERISTALTIC SET?

The FDA 510(k) record lists Laboratorios Grifols, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRI-FILL PERISTALTIC SET?

The FDA product code for GRI-FILL PERISTALTIC SET is LHI.

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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