Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAERSK MEDICAL CONTOUR INFUSION SET

K-Number: K991759 · 1999-06-25

ApplicantMaersk Medical A/S
Decision Date1999-06-25
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAERSK MEDICAL CONTOUR 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 1999-06-25 under 510(k) number K991759. 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 CONTOUR INFUSION SET?

MAERSK MEDICAL CONTOUR INFUSION SET is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is Maersk Medical A/S. The 510(k) number is K991759.

When did MAERSK MEDICAL CONTOUR INFUSION SET receive FDA 510(k) clearance?

MAERSK MEDICAL CONTOUR INFUSION SET received FDA 510(k) clearance on 1999-06-25, under 510(k) number K991759.

Who is the listed applicant for MAERSK MEDICAL CONTOUR 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 MAERSK MEDICAL CONTOUR INFUSION SET?

The FDA product code for MAERSK MEDICAL CONTOUR INFUSION SET is FPA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K011071PARADIGM QUICK-SET INFUSION SETK002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380K990111DISPOSABLE 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

View all 9 devices →

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.

↑