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Percutaneous Introducer Cournand Style

by Dip, Inc. 510(k)

Active United States

510(k) K812973

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812973 Date16 Nov 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0417-2016 FDA Class II initiated 23 Nov 2015

    The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 device is a percutaneous introducer, specifically a Cournand-style needle, used for vascular access procedures. It is classified under product code DYB and regulation 870.1340 as an Introducer, Catheter within the cardiovascular medical specialty.

It received traditional 510(k) clearance (K812973) from the FDA on November 16, 1981, and is classified as a Class II device. The device is supplied as a single unit and is intended for use in cardiovascular access procedures, with no indication of sterility, single-use status, MRI safety, or storage conditions provided in the data.

Other devices from Dip, Inc.