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Medi-Dyne Angiographic Catheter

by Medi-Dyne, Inc.

510(k) K930694

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 NumberK930694 Date2 Aug 1993ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 19 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 Medi-Dyne Angiographic Catheter is a diagnostic intravascular catheter designed for angiographic procedures. It is used to visualize blood vessels, particularly in the cardiovascular system, by injecting contrast media to assess vascular anatomy and identify abnormalities such as blockages or malformations.

This catheter is supplied as a single-use, sterile device intended for use in clinical settings such as catheterization laboratories. It is classified under FDA regulation 870.1200 as a Class II device and has received FDA 510(k) clearance (K930694) under the Cardiovascular advisory committee. The device is not MRI-safe and must be handled according to standard aseptic techniques.

Other devices from Medi-Dyne, Inc.

Questions

AI-generated answers, 19 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 Medi-Dyne Angiographic Catheter used for?

    The Medi-Dyne Angiographic Catheter is a diagnostic intravascular catheter designed for angiographic procedures to visualize blood vessels, particularly in the cardiovascular system, by injecting contrast media to assess vascular anatomy and identify abnormalities such as blockages or malformations.

  • Is the Medi-Dyne Angiographic Catheter reusable or single-use?

    The Medi-Dyne Angiographic Catheter is supplied as a single-use, sterile device intended for use in clinical settings such as catheterization laboratories and must be handled according to standard aseptic techniques.

  • What are the regulatory approvals for the Medi-Dyne Angiographic Catheter?

    The Medi-Dyne Angiographic Catheter has received FDA 510(k) clearance (K930694) under the Cardiovascular advisory committee and is classified under FDA regulation 870.1200 as a Class II device.

  • Is the Medi-Dyne Angiographic Catheter MRI-safe?

    No, the Medi-Dyne Angiographic Catheter is not MRI-safe and should not be used in MRI environments.