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Diagnostic Intravascular Catheter

by Mallinckrodt Critical Care 510(k)

Active United States

510(k) K830415

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830415 Date28 Apr 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
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 Diagnostic Intravascular Catheter is a medical device classified as a Catheter, Intravascular, Diagnostic (product code DQO). It is designed for insertion into blood vessels to facilitate the diagnostic assessment of cardiovascular conditions by enabling the sampling of blood or measurement of pressures within the vascular system.

This device is intended for single-use in clinical settings such as hospitals and cardiac care units. It is regulated under FDA 510(k) clearance (K830415) and falls under Class II – Special Controls. The catheter is supplied sterile and must be handled according to aseptic techniques to ensure patient safety.

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