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FDA 510(k)

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE

K-Number: K971293 · 1997-06-27

ApplicantAbbott Mfg., Inc.
Decision Date1997-06-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Mfg., Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971293. 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 LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE?

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Abbott Mfg., Inc.. The 510(k) number is K971293.

When did LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE receive FDA 510(k) clearance?

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971293.

Who is the listed applicant for LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE?

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

What is the FDA product code for LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE?

The FDA product code for LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE is FPA.

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Other records listing Abbott Mfg., 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.

K981457ALBPK981232CAK981231CO2K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPK953656ABBOTT IMX PROLACTIN(MODIFICATION)K953657ABBOTT AXSYM PROLACTIN(MODIFICATION)

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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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