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FDA 510(k)

PARADIGM QUICK-SET INFUSION SET

K-Number: K011071 · 2001-06-07

ApplicantMaersk Medical A/S
Decision Date2001-06-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARADIGM QUICK-SET INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Maersk Medical A/S. It received FDA 510(k) clearance on 2001-06-07 under 510(k) number K011071. 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 PARADIGM QUICK-SET INFUSION SET?

PARADIGM QUICK-SET INFUSION SET is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Maersk Medical A/S. The 510(k) number is K011071.

When did PARADIGM QUICK-SET INFUSION SET receive FDA 510(k) clearance?

PARADIGM QUICK-SET INFUSION SET received FDA 510(k) clearance on 2001-06-07, under 510(k) number K011071.

Who is the listed applicant for PARADIGM QUICK-SET INFUSION SET?

The FDA 510(k) record lists Maersk Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARADIGM QUICK-SET INFUSION SET?

The FDA product code for PARADIGM QUICK-SET INFUSION SET is FPA.

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Other records listing Maersk Medical A/S 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.

K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440K990111DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140K990112DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560

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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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