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FDA 510(k)

UNICATH LLU ANGIOGRAPHIC SYSTEM

K-Number: K945449 · 1995-02-27

ApplicantXre Corp.
Decision Date1995-02-27
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNICATH LLU ANGIOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K945449. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICATH LLU ANGIOGRAPHIC SYSTEM?

UNICATH LLU ANGIOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Xre Corp.. The 510(k) number is K945449.

When did UNICATH LLU ANGIOGRAPHIC SYSTEM receive FDA 510(k) clearance?

UNICATH LLU ANGIOGRAPHIC SYSTEM received FDA 510(k) clearance on 1995-02-27, under 510(k) number K945449.

Who is the listed applicant for UNICATH LLU ANGIOGRAPHIC SYSTEM?

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

What is the FDA product code for UNICATH LLU ANGIOGRAPHIC SYSTEM?

The FDA product code for UNICATH LLU ANGIOGRAPHIC SYSTEM is IZI.

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Other records listing Xre Corp. as applicant

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Related Devices (Code: IZI)

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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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