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FDA 510(k)

NITROGLYCERIN INFUSION SET

K-Number: K853019 · 1985-11-12

ApplicantLyphomed, Inc.
Decision Date1985-11-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITROGLYCERIN INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Lyphomed, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K853019. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITROGLYCERIN INFUSION SET?

NITROGLYCERIN INFUSION SET is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Lyphomed, Inc.. The 510(k) number is K853019.

When did NITROGLYCERIN INFUSION SET receive FDA 510(k) clearance?

NITROGLYCERIN INFUSION SET received FDA 510(k) clearance on 1985-11-12, under 510(k) number K853019.

Who is the listed applicant for NITROGLYCERIN INFUSION SET?

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

What is the FDA product code for NITROGLYCERIN INFUSION SET?

The FDA product code for NITROGLYCERIN INFUSION SET is FPA.

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Other records listing Lyphomed, Inc. 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.

K910142SPARK KIT(R), MODIFICATIONK864509SPARK-KIT(TM)K853086SECONDARY ADMINISTRATION SETK852882MAXIFILL TRANSFER SETK852881VENTED SECONDARY IV ADMINISTRATION SETK842678I.V. TRANSFER SPIKE

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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