FDA 510(k)

MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR

K-Number: K844957 · 1985-02-08

Decision Date1985-02-08

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1985-02-08 under 510(k) number K844957. 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 MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR?

MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR is a medical device that received FDA 510(k) clearance on 1985-02-08. The listed applicant is Medtronic Vascular. The 510(k) number is K844957.

When did MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR receive FDA 510(k) clearance?

MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR received FDA 510(k) clearance on 1985-02-08, under 510(k) number K844957.

Who is the listed applicant for MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR?

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 8436 -PACEMAKER PULSE GENERATOR?

The FDA product code for MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.