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Manifold

by Medical Specialties Intl., Inc.

510(k) K972654

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 NumberK972654 Date8 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  • Withdrawn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
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

A manifold is a device used in cardiopulmonary bypass systems to distribute fluids or gases. It functions as an adaptor, stopcock, or fitting within cardiovascular medical applications.

This device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization. It is regulated as a Class II medical device under FDA 510(k) clearance K972654, with product code DTL and regulation number 870.4290.

Other devices from Medical Specialties Intl., Inc.

Questions

AI-generated answers, 28 Sep 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 MANIFOLD device used for?

    The MANIFOLD is used in cardiopulmonary bypass systems to distribute fluids or gases, functioning as an adaptor, stopcock, or fitting within cardiovascular medical applications.

  • Is the MANIFOLD supplied sterile or non-sterile, and is it intended for single use or reuse?

    The MANIFOLD is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization, as stated in the device description.

  • What regulatory pathway and classification apply to the MANIFOLD device?

    The MANIFOLD is regulated as a Class II medical device under FDA 510(k) clearance K972654, with product code DTL and regulation number 870.4290.