FDA 510(k)

PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION

K-Number: K914116 · 1991-11-27

Decision Date1991-11-27

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914116. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION?

PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Medtronic Vascular. The 510(k) number is K914116.

When did PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION receive FDA 510(k) clearance?

PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914116.

Who is the listed applicant for PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION?

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

What is the FDA product code for PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION?

The FDA product code for PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION is DSY.

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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.