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FDA 510(k)

VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES

K-Number: K950153 · 1995-08-24

ApplicantImed Corp.
Decision Date1995-08-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K950153. 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 VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES?

VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Imed Corp.. The 510(k) number is K950153.

When did VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES receive FDA 510(k) clearance?

VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES received FDA 510(k) clearance on 1995-08-24, under 510(k) number K950153.

Who is the listed applicant for VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES?

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

What is the FDA product code for VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES?

The FDA product code for VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES is FPA.

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Other records listing Imed 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.

K960512GEMINI PC-ITXK953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSK951922ADMINISTRATION SETS WITH BALL FLOATK950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSK944320VENTED/NON-VENTED GEMINI ADMINISTRATION SETK945070VERSASAE PLASTIC CANNULA- 11 GAUGE

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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