Skip to content

Mikro-Tip Angiographic Catheter

by Millar Instruments, Inc. 2 variants

510(k) K993694

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 · Special NumberK993694 Date1 Mar 2000ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1725-2011 FDA Unclassified (pre-2012) initiated 8 Mar 2011

    Possibility of epoxy debris particles inside the catheter lumen.

    • Terminated Z-0401-2011 FDA Unclassified (pre-2012) initiated 14 Oct 2010

    The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.

    • Terminated Z-0635-05 FDA Unclassified (pre-2012) initiated 14 Jan 2005

    Wire braiding protruding from the catheter.

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The MIKRO-TIP ANGIOGRAPHIC CATHETER is a single pressure catheter designed for measuring arterial and ventricular blood pressures, spinal pressures, tumor pressures, or airway pressures in small and large animal models. It features a high-fidelity pressure sensor side-mounted at the catheter tip and is available in sizes ranging from 1 F (0.33 mm) to 6 F (2 mm) in diameter, with straight and curved tip options.

The catheter is supplied as a single-use device and is intended for pre-clinical applications. It is not sterilized and must be stored in a dry environment. The device is authorized by the FDA under 510(k) clearance (K993694) and is classified under product code DQO.

Other devices from Millar Instruments, Inc.

See all devices from Millar Instruments, Inc. →

Questions

AI-generated answers, 23 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 MIKRO-TIP ANGIOGRAPHIC CATHETER used for?

    This catheter is designed for pre-clinical applications to measure arterial and ventricular blood pressures, as well as spinal, tumor, and airway pressures in both small and large animal models.

  • Is the MIKRO-TIP ANGIOGRAPHIC CATHETER sterile?

    No, the device is not sterile and must be stored in a dry environment. It is supplied as a single-use device for pre-clinical applications.

  • What sizes and options are available for the MIKRO-TIP ANGIOGRAPHIC CATHETER?

    It is available in sizes ranging from 1 F (0.33 mm) to 6 F (2 mm) in diameter, with both straight and curved tip options.

  • How is the MIKRO-TIP ANGIOGRAPHIC CATHETER regulated?

    The device is authorized by the FDA under 510(k) clearance (K993694) and is classified under product code DQO.