Decision Date1984-08-29
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MEDTRONIC 8437/8438 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1984-08-29 under 510(k) number K843089. 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 8437/8438?
MEDTRONIC 8437/8438 is a medical device that received FDA 510(k) clearance on 1984-08-29. The listed applicant is Medtronic Vascular. The 510(k) number is K843089.
When did MEDTRONIC 8437/8438 receive FDA 510(k) clearance?
MEDTRONIC 8437/8438 received FDA 510(k) clearance on 1984-08-29, under 510(k) number K843089.
Who is the listed applicant for MEDTRONIC 8437/8438?
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 8437/8438?
The FDA product code for MEDTRONIC 8437/8438 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.