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FDA 510(k)

SPARK KIT(R), MODIFICATION

K-Number: K910142 · 1991-05-14

ApplicantLyphomed, Inc.
Decision Date1991-05-14
Product CodeFPA
Advisory CommitteeHO
DecisionUnknown

Device Summary

SPARK KIT(R), MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lyphomed, Inc.. It received FDA 510(k) clearance on 1991-05-14 under 510(k) number K910142. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SPARK KIT(R), MODIFICATION?

SPARK KIT(R), MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-05-14. The listed applicant is Lyphomed, Inc.. The 510(k) number is K910142.

When did SPARK KIT(R), MODIFICATION receive FDA 510(k) clearance?

SPARK KIT(R), MODIFICATION received FDA 510(k) clearance on 1991-05-14, under 510(k) number K910142.

Who is the listed applicant for SPARK KIT(R), MODIFICATION?

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 SPARK KIT(R), MODIFICATION?

The FDA product code for SPARK KIT(R), MODIFICATION 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.

K864509SPARK-KIT(TM)K853019NITROGLYCERIN INFUSION SETK853086SECONDARY 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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