Decision Date1995-07-12
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.
Device Summary
PELLETHANE 75D is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K940039. 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 - Subject to Tracking Reg..
Frequently Asked Questions
What is the PELLETHANE 75D?
PELLETHANE 75D is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Medtronic Vascular. The 510(k) number is K940039.
When did PELLETHANE 75D receive FDA 510(k) clearance?
PELLETHANE 75D received FDA 510(k) clearance on 1995-07-12, under 510(k) number K940039.
Who is the listed applicant for PELLETHANE 75D?
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 PELLETHANE 75D?
The FDA product code for PELLETHANE 75D 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.