Percutaneous Introducer W/Side Port 3 Way Stopcock

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K870374 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

See all devices from Daig Corp. →

• What is the primary purpose of the percutaneous introducer with a side port and 3-way stopcock from Daig Corp.?

  This device is designed to help healthcare providers insert catheters into blood vessels. The side port allows for additional fluid administration or monitoring of pressure, while the integrated 3-way stopcock enables precise control over fluid flow during procedures.

• How is this device supplied, and what does the FDA clearance indicate about its regulatory status?

  The device is supplied by Daig Corp. and is cleared under FDA 510(k) with the reference number K870374, indicating it was determined *substantially equivalent* to a legally marketed predicate device. The clearance was granted on March 18, 1987, under the Cardiovascular (CV) Advisory Committee and classified as Class II – Special Controls with product code DYB (Introducer, Catheter).

• Is this device intended for single-use or can it be reused? How should it be stored?

  The provided data does not specify reuse restrictions, but the lack of explicit mention of sterilization or reprocessing instructions suggests it is likely intended for single-use in clinical settings. Storage conditions are not detailed, but standard medical device storage practices—such as keeping it in a clean, dry environment away from direct sunlight—should be followed until use.

• What sizes or models of this introducer are available, and does Daig Corp. provide any additional details on customization?

  The specifications do not list specific sizes or models of the introducer, nor does the data mention customization options. For exact dimensions or available variants, contacting Daig Corp. directly at their address (14901 Deveau Pl., Minnetonka, MN 55345) or via their contact (John Fleischhacker) would be necessary.