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)

CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP

K-Number: K013714 · 2002-03-28

ApplicantCodan US Corp.
Decision Date2002-03-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP is the device name listed in this FDA 510(k) record. The listed applicant is Codan US Corp.. It received FDA 510(k) clearance on 2002-03-28 under 510(k) number K013714. 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 CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP?

CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP is a medical device that received FDA 510(k) clearance on 2002-03-28. The listed applicant is Codan US Corp.. The 510(k) number is K013714.

When did CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP receive FDA 510(k) clearance?

CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP received FDA 510(k) clearance on 2002-03-28, under 510(k) number K013714.

Who is the listed applicant for CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP?

The FDA 510(k) record lists Codan US Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP?

The FDA product code for CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP 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 Codan US Corp. 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.

K112268CODAN SAFEFEED ENTERAL FEEDING RESERVOIRK042693IV ADMINISTRATION SET B400 SPK033301IV ADMINISTRATION AND CONNECT SETSK021480EXTENSION SET LIGHT-SAFE, MODEL BC565K001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411K990711CODAN CHEMOSPIKE

View all 7 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.

↑