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Percutaneous Venous Introducer 10264

by Medamicus, Inc.

510(k) K965167

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK965167 Date25 Jul 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
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 Percutaneous Venous Introducer 10264 is a medical device designed to provide access to the venous system for the insertion of catheters, ports, and pacing leads. It is intended to create a percutaneous pathway for the introduction of these devices into the venous vasculature.

Manufactured by Medamicus, Inc., the device was cleared through the FDA 510(k) pathway on July 25, 1997, under K965167 and is classified as a Class 2 device under product code DYB. It is supplied as a single-use device for use in clinical settings where venous access is required.

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Questions

AI-generated answers, 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.

  • What is the Percutaneous Venous Introducer 10264 used for?

    The Percutaneous Venous Introducer 10264 is designed to create a percutaneous pathway into the venous system to allow insertion of catheters, ports, and pacing leads. It facilitates venous access for these devices in clinical settings.

  • Is the Percutaneous Venous Introducer 10264 reusable or single-use?

    The Percutaneous Venous Introducer 10264 is supplied as a single-use device, meaning it is intended for one patient and one procedure only, then discarded to prevent cross-contamination and ensure sterility.

  • How was the Percutaneous Venous Introducer 10264 cleared for market?

    The Percutaneous Venous Introducer 10264 received market clearance through the FDA 510(k) pathway on July 25, 1997, under submission K965167, demonstrating substantial equivalence to a predicate device.