FDA 510(k)

MODIFIED MODELS 8320/8322/8329/8316/8317/8318

K-Number: K861719 · 1986-07-01

Decision Date1986-07-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFIED MODELS 8320/8322/8329/8316/8317/8318 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K861719. 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 MODIFIED MODELS 8320/8322/8329/8316/8317/8318?

MODIFIED MODELS 8320/8322/8329/8316/8317/8318 is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Medtronic Vascular. The 510(k) number is K861719.

When did MODIFIED MODELS 8320/8322/8329/8316/8317/8318 receive FDA 510(k) clearance?

MODIFIED MODELS 8320/8322/8329/8316/8317/8318 received FDA 510(k) clearance on 1986-07-01, under 510(k) number K861719.

Who is the listed applicant for MODIFIED MODELS 8320/8322/8329/8316/8317/8318?

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 MODIFIED MODELS 8320/8322/8329/8316/8317/8318?

The FDA product code for MODIFIED MODELS 8320/8322/8329/8316/8317/8318 is DXY. This falls under the Clinical Chemistry category.

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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.