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FDA 510(k)

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET

K-Number: K964812 · 1997-02-10

ApplicantCritical Device Corp.
Decision Date1997-02-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET is the device name listed in this FDA 510(k) record. The listed applicant is Critical Device Corp.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K964812. 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 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET?

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Critical Device Corp.. The 510(k) number is K964812.

When did NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET receive FDA 510(k) clearance?

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET received FDA 510(k) clearance on 1997-02-10, under 510(k) number K964812.

Who is the listed applicant for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET?

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

What is the FDA product code for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET?

The FDA product code for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. 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.

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 Critical Device 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.

K983926MPS GRAVITY FLOW CONTROL SETK964918NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETSK964989CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)K952852NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SETK955896MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

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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