FDA 510(k)

MODEL 5866-46 SLEEVE KIT

K-Number: K910568 · 1991-04-09

Decision Date1991-04-09

Product CodeDTP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 5866-46 SLEEVE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-04-09 under 510(k) number K910568. The device is classified under product code DTP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5866-46 SLEEVE KIT?

MODEL 5866-46 SLEEVE KIT is a medical device that received FDA 510(k) clearance on 1991-04-09. The listed applicant is Medtronic Vascular. The 510(k) number is K910568.

When did MODEL 5866-46 SLEEVE KIT receive FDA 510(k) clearance?

MODEL 5866-46 SLEEVE KIT received FDA 510(k) clearance on 1991-04-09, under 510(k) number K910568.

Who is the listed applicant for MODEL 5866-46 SLEEVE KIT?

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 MODEL 5866-46 SLEEVE KIT?

The FDA product code for MODEL 5866-46 SLEEVE KIT is DTP.

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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.