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FDA 510(k)

SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET

K-Number: K052658 · 2005-10-12

ApplicantRenascence Medical, Inc.
Decision Date2005-10-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Renascence Medical, Inc.. It received FDA 510(k) clearance on 2005-10-12 under 510(k) number K052658. 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 SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET?

SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 2005-10-12. The listed applicant is Renascence Medical, Inc.. The 510(k) number is K052658.

When did SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET receive FDA 510(k) clearance?

SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET received FDA 510(k) clearance on 2005-10-12, under 510(k) number K052658.

Who is the listed applicant for SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET?

The FDA 510(k) record lists Renascence Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET?

The FDA product code for SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET is FPA.

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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

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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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