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Mediastinal Autotransfusion System

by Cardio Metrics, Inc. 510(k)

Active United States

510(k) K860775

Overview

The Mediastinal Autotransfusion System is a Class 2 cardiovascular device with product code DTP. It is designed for autotransfusion of mediastinal blood during cardiovascular procedures.

The device is supplied by Cardio Metrics, Inc. and received FDA 510(k) clearance on May 28, 1986. It is regulated under product code DTP and is intended for use in cardiovascular procedures.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860775 Date28 May 1986ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTP
Device Class
Class II
Regulation
21 CFR Part 870.4230
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Mediastinal Autotransfusion System used for?

    The Mediastinal Autotransfusion System is designed for autotransfusion of mediastinal blood during cardiovascular procedures. It helps collect and return a patient's own blood lost during surgery, reducing the need for donor blood transfusions.

  • How is the Mediastinal Autotransfusion System supplied?

    The Mediastinal Autotransfusion System is supplied by Cardio Metrics, Inc. It is a Class 2 cardiovascular device with product code DTP, specifically designed for use in cardiovascular procedures where autotransfusion of mediastinal blood is required.

  • What is the regulatory status of the Mediastinal Autotransfusion System?

    The Mediastinal Autotransfusion System received FDA 510(k) clearance on May 28, 1986. It is regulated under product code DTP and was determined to be substantially equivalent to other devices in its class for cardiovascular procedures.

  • Is the Mediastinal Autotransfusion System single-use or reusable?

    The device data does not specify whether the Mediastinal Autotransfusion System is designed for single-use or multiple uses. For specific information regarding reuse or disposal, please consult the manufacturer's instructions or contact Cardio Metrics, Inc. directly.