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FDA 510(k)

NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505

K-Number: K092246 · 2009-11-12

ApplicantNipro Medical Corporation
Decision Date2009-11-12
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K092246. 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 NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505?

NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 is a medical device that received FDA 510(k) clearance on 2009-11-12. The listed applicant is Nipro Medical Corporation. The 510(k) number is K092246.

When did NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 receive FDA 510(k) clearance?

NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 received FDA 510(k) clearance on 2009-11-12, under 510(k) number K092246.

Who is the listed applicant for NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505?

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

What is the FDA product code for NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505?

The FDA product code for NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 is LHI.

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Other records listing Nipro Medical Corporation as applicant

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Related Devices (Code: LHI)

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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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