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FDA 510(k)

INTRAVASCULAR ADMINISTRATION SET

K-Number: K121803 · 2012-12-19

ApplicantActa Medical, LLC
Decision Date2012-12-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Acta Medical, LLC. It received FDA 510(k) clearance on 2012-12-19 under 510(k) number K121803. 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 INTRAVASCULAR ADMINISTRATION SET?

INTRAVASCULAR ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 2012-12-19. The listed applicant is Acta Medical, LLC. The 510(k) number is K121803.

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

INTRAVASCULAR ADMINISTRATION SET received FDA 510(k) clearance on 2012-12-19, under 510(k) number K121803.

Who is the listed applicant for INTRAVASCULAR ADMINISTRATION SET?

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

What is the FDA product code for INTRAVASCULAR ADMINISTRATION SET?

The FDA product code for INTRAVASCULAR ADMINISTRATION 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.

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Other records listing Acta Medical, LLC 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.

K121161EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINERK112863ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN

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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