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FDA 510(k)

MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET

K-Number: K972135 · 1997-08-26

ApplicantP/L Biomedical
Decision Date1997-08-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is P/L Biomedical. It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K972135. 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 MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET?

MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is P/L Biomedical. The 510(k) number is K972135.

When did MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET receive FDA 510(k) clearance?

MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972135.

Who is the listed applicant for MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET?

The FDA 510(k) record lists P/L Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET?

The FDA product code for MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET is FPA.

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Other records listing P/L Biomedical 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.

K122971CLICKFINE PEN NEEDLEK122969CLICKFINE PEN NEEDLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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