FDA 510(k)

MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL

K-Number: K971474 · 1997-07-14

Decision Date1997-07-14

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K971474. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL?

MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Medtronic Vascular. The 510(k) number is K971474.

When did MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL receive FDA 510(k) clearance?

MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL received FDA 510(k) clearance on 1997-07-14, under 510(k) number K971474.

Who is the listed applicant for MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL?

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 MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL?

The FDA product code for MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL is DTE.

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Related Devices (Code: DTE)

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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.