FDA 510(k)

ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE

K-Number: K823256 · 1982-12-30

Decision Date1982-12-30

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE 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 K823256. 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 ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE?

ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE 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 K823256.

When did ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE receive FDA 510(k) clearance?

ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823256.

Who is the listed applicant for ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE?

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 ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE?

The FDA product code for ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE is DXT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.