FDA 510(k)

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS

K-Number: K964918 · 1997-04-14

Decision Date1997-04-14

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS 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 1997-04-14 under 510(k) number K964918. 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 WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS?

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is Critical Device Corp.. The 510(k) number is K964918.

When did NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS receive FDA 510(k) clearance?

NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS received FDA 510(k) clearance on 1997-04-14, under 510(k) number K964918.

Who is the listed applicant for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS?

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 WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS?

The FDA product code for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS 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 Critical Device Corp. as applicant

K983926MPS GRAVITY FLOW CONTROL SET K964989CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)K964812NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET K952852NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET K955896MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

Related Devices (Code: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe 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 Medical K250325BD 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.