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FDA 510(k)

APEX TUBING SET

K-Number: K954440 · 1995-11-02

ApplicantLinvatec Corp.
Decision Date1995-11-02
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1995-11-02 under 510(k) number K954440. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX TUBING SET?

APEX TUBING SET is a medical device that received FDA 510(k) clearance on 1995-11-02. The listed applicant is Linvatec Corp.. The 510(k) number is K954440.

When did APEX TUBING SET receive FDA 510(k) clearance?

APEX TUBING SET received FDA 510(k) clearance on 1995-11-02, under 510(k) number K954440.

Who is the listed applicant for APEX TUBING SET?

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

What is the FDA product code for APEX TUBING SET?

The FDA product code for APEX TUBING SET is HRX.

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Related Devices (Code: HRX)

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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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