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Percutaneous Introducers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K903530

by Davol Inc.

Identifiers

510(k) Number
K903530 FDA 510(k)
FDA Product Code
DYB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PERCUTANEOUS INTRODUCERS (K903530) — FDA 510 (k) | Innolitics, Percutaneous Introducers - Davol | FDA Evidence Review, PDF K903530 - Percutaneous Introducers, PERCUTANEOUS INTRODUCERS 510(k) K903530 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Davol Inc.
FDA Applicant
Davol, Inc.

Sources (1)

  • FDA 510(k) K903530 24 fields · synced Sep 19, 2026