FDA 510(k)

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN

K-Number: K862037 · 1986-06-17

Decision Date1986-06-17

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1986-06-17 under 510(k) number K862037. 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 MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN?

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN is a medical device that received FDA 510(k) clearance on 1986-06-17. The listed applicant is Medtronic Vascular. The 510(k) number is K862037.

When did MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN receive FDA 510(k) clearance?

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN received FDA 510(k) clearance on 1986-06-17, under 510(k) number K862037.

Who is the listed applicant for MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN?

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 MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN?

The FDA product code for MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.