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FDA 510(k)

PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

K-Number: K071421 · 2007-10-04

ApplicantPromepla
Decision Date2007-10-04
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Promepla. It received FDA 510(k) clearance on 2007-10-04 under 510(k) number K071421. 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 PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET?

PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET is a medical device that received FDA 510(k) clearance on 2007-10-04. The listed applicant is Promepla. The 510(k) number is K071421.

When did PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET receive FDA 510(k) clearance?

PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET received FDA 510(k) clearance on 2007-10-04, under 510(k) number K071421.

Who is the listed applicant for PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET?

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

What is the FDA product code for PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET?

The FDA product code for PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION 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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