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Cts Midcab Fixedn Diameter Coronary Shunt

by Cardiothoracic Systems, Inc.

510(k) K970638

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 NumberK970638 Date30 Oct 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  • Withdrawn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, 6 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 CTS MIDCAB Fixed Diameter Coronary Shunt is a cardiovascular device designed for use in minimally invasive direct coronary artery bypass (MIDCAB) procedures. It is intended to facilitate blood flow during coronary artery bypass grafting by providing a shunt with a fixed diameter.

The device is supplied by Cardiothoracic Systems, Inc. and has received FDA 510(k) clearance under K970638. It is classified under product code DXC and was determined to be substantially equivalent to a predicate device. The shunt is used in cardiovascular surgical settings and is not described as sterile, single-use, reusable, MRI safe, or with specific size or storage details in the provided data.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the CTS MIDCAB Fixed Diameter Coronary Shunt used for?

    The CTS MIDCAB Fixed Diameter Coronary Shunt is designed for use in minimally invasive direct coronary artery bypass (MIDCAB) procedures to facilitate blood flow during coronary artery bypass grafting by providing a shunt with a fixed diameter.

  • Who manufactures the CTS MIDCAB Fixed Diameter Coronary Shunt?

    The CTS MIDCAB Fixed Diameter Coronary Shunt is supplied by Cardiothoracic Systems, Inc., located at 10600 N. Tantau Ave., Cupertino, CA 95014, United States.

  • What regulatory clearance does the CTS MIDCAB Fixed Diameter Coronary Shunt have?

    The device has received FDA 510(k) clearance under K970638 and was determined to be substantially equivalent to a predicate device, with a traditional clearance type and decision date of October 30, 1997.

  • Is the CTS MIDCAB Fixed Diameter Coronary Shunt sterile or single-use?

    The provided data does not describe the shunt as sterile, single-use, or reusable, so no information on sterility or reuse is available from the device specifications.

  • What sizes or models are available for the CTS MIDCAB Fixed Diameter Coronary Shunt?

    The device data does not specify any sizes, models, or reference numbers beyond the fixed diameter characteristic, so no size variations or model details are provided.