FDA 510(k)

MEDTRONIC PERMANENT LEAD INTRODUCER

K-Number: K854559 · 1985-12-24

Decision Date1985-12-24

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC PERMANENT LEAD INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1985-12-24 under 510(k) number K854559. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC PERMANENT LEAD INTRODUCER?

MEDTRONIC PERMANENT LEAD INTRODUCER is a medical device that received FDA 510(k) clearance on 1985-12-24. The listed applicant is Medtronic Vascular. The 510(k) number is K854559.

When did MEDTRONIC PERMANENT LEAD INTRODUCER receive FDA 510(k) clearance?

MEDTRONIC PERMANENT LEAD INTRODUCER received FDA 510(k) clearance on 1985-12-24, under 510(k) number K854559.

Who is the listed applicant for MEDTRONIC PERMANENT LEAD INTRODUCER?

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 MEDTRONIC PERMANENT LEAD INTRODUCER?

The FDA product code for MEDTRONIC PERMANENT LEAD INTRODUCER is DYB.

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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.