FDA 510(k)

VERTEX MONITORING CATHETER

K-Number: K823253 · 1982-12-30

Decision Date1982-12-30

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VERTEX MONITORING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vertex Medical Corp.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823253. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEX MONITORING CATHETER?

VERTEX MONITORING CATHETER is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Vertex Medical Corp.. The 510(k) number is K823253.

When did VERTEX MONITORING CATHETER receive FDA 510(k) clearance?

VERTEX MONITORING CATHETER received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823253.

Who is the listed applicant for VERTEX MONITORING CATHETER?

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

What is the FDA product code for VERTEX MONITORING CATHETER?

The FDA product code for VERTEX MONITORING CATHETER is DXT.

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Other records listing Vertex Medical Corp. as applicant

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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.