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FDA 510(k)

TWOFER NEEDLE

K-Number: K832347 · 1983-09-12

ApplicantBaxa Corp., Sub. of Cook Group, Inc.
Decision Date1983-09-12
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TWOFER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832347. 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 TWOFER NEEDLE?

TWOFER NEEDLE is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. The 510(k) number is K832347.

When did TWOFER NEEDLE receive FDA 510(k) clearance?

TWOFER NEEDLE received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832347.

Who is the listed applicant for TWOFER NEEDLE?

The FDA 510(k) record lists Baxa Corp., Sub. of Cook Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWOFER NEEDLE?

The FDA product code for TWOFER NEEDLE is LHI.

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Other records listing Baxa Corp., Sub. of Cook Group, Inc. as applicant

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K910257BAXA PCA INFUSORK903159VALVE CONTROLLER FOR MICROMACRO COMPOUNDERK904225KWIKMIXK900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPK873875BAXA EXACTA-MED PHARMACY PUMPK872743BAXA TUBING SETS (FOR PHARMACY PUMP)

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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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