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FDA 510(k)

MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG

K-Number: K861434 · 1986-05-01

ApplicantChurchill Corp.
Decision Date1986-05-01
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG is the device name listed in this FDA 510(k) record. The listed applicant is Churchill Corp.. It received FDA 510(k) clearance on 1986-05-01 under 510(k) number K861434. 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 MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG?

MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG is a medical device that received FDA 510(k) clearance on 1986-05-01. The listed applicant is Churchill Corp.. The 510(k) number is K861434.

When did MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG receive FDA 510(k) clearance?

MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG received FDA 510(k) clearance on 1986-05-01, under 510(k) number K861434.

Who is the listed applicant for MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG?

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

What is the FDA product code for MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG?

The FDA product code for MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG is LHI.

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Other records listing Churchill Corp. 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.

K880026CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETSK880051ENTERAL BAG/SETK880025CHURCHILL 0.22 MICRON LIQUID FILTER SETSK880027CHURCHILL 1.2 MICRON LIQUID FILTER SETK870395CHURCHILL PARENTERAL NUTRITION BAG - EVAK872585CHURCHILL-CATH

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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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