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FDA 510(k)

MICS DEVICE SYSTEM

K-Number: K963716 · 1997-04-02

ApplicantPercutaneous Technologies, Inc.
Decision Date1997-04-02
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICS DEVICE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Percutaneous Technologies, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K963716. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICS DEVICE SYSTEM?

MICS DEVICE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Percutaneous Technologies, Inc.. The 510(k) number is K963716.

When did MICS DEVICE SYSTEM receive FDA 510(k) clearance?

MICS DEVICE SYSTEM received FDA 510(k) clearance on 1997-04-02, under 510(k) number K963716.

Who is the listed applicant for MICS DEVICE SYSTEM?

The FDA 510(k) record lists Percutaneous Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICS DEVICE SYSTEM?

The FDA product code for MICS DEVICE SYSTEM is DXC.

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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.

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