Vertex Percutaneous Catheter Introduc

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

510(k) Number

K840017 ↗

FDA Product Code

DRE

Device Class

Class II

Regulation

21 CFR Part 870.1310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Vertex Percutaneous Catheter Introducer used for?

  The Vertex Percutaneous Catheter Introducer is a vessel dilator designed for percutaneous catheterization procedures. It is placed over a guide wire to enlarge the opening in a vessel, then removed before sliding the catheter over the guide wire.

• How is the Vertex Percutaneous Catheter Introducer supplied?

  The device is supplied in various sizes as indicated by the multiple registration numbers associated with this FDA clearance. Each size is designed to accommodate different clinical needs during cardiovascular procedures.

• What is the regulatory status of the Vertex Percutaneous Catheter Introducer?

  The Vertex Percutaneous Catheter Introducer is classified under product code DRE as a Class II medical device with special controls. It received FDA 510(k) clearance on February 4, 1984, with K number K840017.

• Is the Vertex Percutaneous Catheter Introducer single-use or reusable?

  The device description does not specify whether it is single-use or reusable. As a Class II medical device with special controls, the intended use and disposal instructions would be provided in the product labeling and instructions for use.