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Cortez Needle Free IV Connector, Model MMD-001

by Mission Medicl Devices

510(k) K003254

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 NumberK003254 Date9 Jul 2001ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
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 Cortez Needle Free IV Connector, Model MMD-001 is a set, administration, intravascular medical device. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.

The device is supplied by Mission Medicl Devices and is intended for use in general hospital settings. It has product code FPA and was cleared on July 9, 2001, under K003254.

Questions

AI-generated answers, 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.

  • What is the Cortez Needle Free IV Connector, Model MMD-001 used for?

    The Cortez Needle Free IV Connector, Model MMD-001 is an intravascular administration set intended for use in general hospital settings to connect intravenous lines without needles, based on its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • How is the Cortez Needle Free IV Connector, Model MMD-001 supplied and by whom?

    The device is supplied by Mission Medicl Devices from their address at 3525 Del Mar Heights Rd. #430, San Diego, CA 92130, as indicated in the manufacturer and address fields of the FDA 510(k) submission.

  • What regulatory pathway was used for the Cortez Needle Free IV Connector, Model MMD-001?

    The device received traditional 510(k) clearance from the FDA under K003254 on July 9, 2001, based on a determination of substantial equivalence to a predicate device, as stated in the decision description and clearance type fields.