FDA 510(k)

PROGRAMMER, MEDTRONIC MODEL 5984/5985

K-Number: K791181 · 1979-09-20

Decision Date1979-09-20

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PROGRAMMER, MEDTRONIC MODEL 5984/5985 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1979-09-20 under 510(k) number K791181. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGRAMMER, MEDTRONIC MODEL 5984/5985?

PROGRAMMER, MEDTRONIC MODEL 5984/5985 is a medical device that received FDA 510(k) clearance on 1979-09-20. The listed applicant is Medtronic Vascular. The 510(k) number is K791181.

When did PROGRAMMER, MEDTRONIC MODEL 5984/5985 receive FDA 510(k) clearance?

PROGRAMMER, MEDTRONIC MODEL 5984/5985 received FDA 510(k) clearance on 1979-09-20, under 510(k) number K791181.

Who is the listed applicant for PROGRAMMER, MEDTRONIC MODEL 5984/5985?

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 PROGRAMMER, MEDTRONIC MODEL 5984/5985?

The FDA product code for PROGRAMMER, MEDTRONIC MODEL 5984/5985 is DXY. This falls under the Clinical Chemistry category.

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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.