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FDA 510(k)

IMED GRAVISET INTRAVASCULAR ADMIN. SET

K-Number: K851360 · 1985-05-08

ApplicantImed Corp.
Decision Date1985-05-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMED GRAVISET INTRAVASCULAR ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1985-05-08 under 510(k) number K851360. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMED GRAVISET INTRAVASCULAR ADMIN. SET?

IMED GRAVISET INTRAVASCULAR ADMIN. SET is a medical device that received FDA 510(k) clearance on 1985-05-08. The listed applicant is Imed Corp.. The 510(k) number is K851360.

When did IMED GRAVISET INTRAVASCULAR ADMIN. SET receive FDA 510(k) clearance?

IMED GRAVISET INTRAVASCULAR ADMIN. SET received FDA 510(k) clearance on 1985-05-08, under 510(k) number K851360.

Who is the listed applicant for IMED GRAVISET INTRAVASCULAR ADMIN. SET?

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 IMED GRAVISET INTRAVASCULAR ADMIN. SET?

The FDA product code for IMED GRAVISET INTRAVASCULAR ADMIN. SET is FRN.

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Other records listing Imed Corp. as applicant

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K960512GEMINI PC-ITXK953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSK950153VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVESK951922ADMINISTRATION SETS WITH BALL FLOATK950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSK944320VENTED/NON-VENTED GEMINI ADMINISTRATION SET

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Related Devices (Code: FRN)

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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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