FDA 510(k)

VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM

K-Number: K954433 · 1995-11-15

Decision Date1995-11-15

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1995-11-15 under 510(k) number K954433. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM?

VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-15. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K954433.

When did VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM receive FDA 510(k) clearance?

VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1995-11-15, under 510(k) number K954433.

Who is the listed applicant for VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM?

The FDA 510(k) record lists Gish Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM?

The FDA product code for VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM is LJT.

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Other records listing Gish Biomedical, Inc. as applicant

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Related Devices (Code: LJT)

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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.