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FDA 510(k)

UNIVERSAL CANNULA SYSTEM

K-Number: K863590 · 1986-10-23

ApplicantAspen Laboratories, Inc.
Decision Date1986-10-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL CANNULA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1986-10-23 under 510(k) number K863590. 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 UNIVERSAL CANNULA SYSTEM?

UNIVERSAL CANNULA SYSTEM is a medical device that received FDA 510(k) clearance on 1986-10-23. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K863590.

When did UNIVERSAL CANNULA SYSTEM receive FDA 510(k) clearance?

UNIVERSAL CANNULA SYSTEM received FDA 510(k) clearance on 1986-10-23, under 510(k) number K863590.

Who is the listed applicant for UNIVERSAL CANNULA SYSTEM?

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

What is the FDA product code for UNIVERSAL CANNULA SYSTEM?

The FDA product code for UNIVERSAL CANNULA SYSTEM is 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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