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MICS Device System

by Percutaneous Technologies, Inc.

510(k) K963716

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963716 Date2 Apr 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MICS Device System is a vascular clamp, classified under product code DXC, designed for percutaneous vascular access procedures. It is intended for securing and stabilizing blood vessels during interventions, facilitating controlled access while minimizing trauma to surrounding tissues. This device is engineered to support minimally invasive cardiac and vascular applications, ensuring precision and reliability in clinical settings.

The system is supplied as a reusable medical device and has received FDA 510(k) clearance under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) issued on April 2, 1997. It is intended for use in controlled environments such as catheterization labs or operating rooms, adhering to standard sterility and handling protocols. The device is regulated under Class II Special Controls and is manufactured by Percutaneous Technologies, Inc., with regulatory filing details available under K-number K963716.

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