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FDA 510(k)

EXTENSION SET LIGHT-SAFE, MODEL BC565

K-Number: K021480 · 2002-06-27

ApplicantCodan US Corp.
Decision Date2002-06-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXTENSION SET LIGHT-SAFE, MODEL BC565 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 2002-06-27 under 510(k) number K021480. 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 EXTENSION SET LIGHT-SAFE, MODEL BC565?

EXTENSION SET LIGHT-SAFE, MODEL BC565 is a medical device that received FDA 510(k) clearance on 2002-06-27. The listed applicant is Codan US Corp.. The 510(k) number is K021480.

When did EXTENSION SET LIGHT-SAFE, MODEL BC565 receive FDA 510(k) clearance?

EXTENSION SET LIGHT-SAFE, MODEL BC565 received FDA 510(k) clearance on 2002-06-27, under 510(k) number K021480.

Who is the listed applicant for EXTENSION SET LIGHT-SAFE, MODEL BC565?

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 EXTENSION SET LIGHT-SAFE, MODEL BC565?

The FDA product code for EXTENSION SET LIGHT-SAFE, MODEL BC565 is FPA.

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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 SETSK013714CODAN US I.V. ADMINISTRATION SET, MODEL B400 SPK001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411K990711CODAN CHEMOSPIKE

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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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