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FDA 510(k)

PROTECTIVE SLEEVE

K-Number: K832380 · 1983-11-28

ApplicantVertex Medical Corp.
Decision Date1983-11-28
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROTECTIVE SLEEVE 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 1983-11-28 under 510(k) number K832380. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTIVE SLEEVE?

PROTECTIVE SLEEVE is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Vertex Medical Corp.. The 510(k) number is K832380.

When did PROTECTIVE SLEEVE receive FDA 510(k) clearance?

PROTECTIVE SLEEVE received FDA 510(k) clearance on 1983-11-28, under 510(k) number K832380.

Who is the listed applicant for PROTECTIVE SLEEVE?

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 PROTECTIVE SLEEVE?

The FDA product code for PROTECTIVE SLEEVE is DYG.

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Other records listing Vertex Medical Corp. as applicant

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Related Devices (Code: DYG)

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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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