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Percutaneous Introducers

by Davol Inc.

510(k) K903530

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903530 Date22 Oct 1990ClearedStatusActive

Official records

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  • Withdrawn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
DYB
FDA applicant
Davol, Inc.
Device class
Class II
Regulation
21 CFR Part 870.1340
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 Percutaneous Introducers are sterile, single-use medical devices designed for vascular access. They facilitate the insertion of catheters, guidewires, or other intravascular devices into the bloodstream through a small incision in the skin, enabling procedures such as angiography, hemodialysis, or pacemaker implantation.

These devices are supplied as sterile, disposable instruments and are intended for use in clinical settings such as hospitals and outpatient care facilities. They are classified under FDA product code DYB and were granted a Traditional 510(k) clearance in 1990, with a decision of Substantially Equivalent by the Cardiovascular Advisory Committee. No additional regulatory status beyond the stated FDA_510K authorization is implied.

Similar devices

Other devices filed under FDA product code DYB (Introducer, Catheter).

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