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PSG EDM Infusion Catheter

by Peripheral Systems Group

510(k) K895932

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 NumberK895932 Date4 Jan 1990ClearedStatusActive

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  • Withdrawn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)

Full name
Psg(Tm) Edm(Tm) Infusion Catheter
510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This is a Catheter, Percutaneous (product code DQY), a specialized catheter designed for the infusion of therapeutic agents into the venous system. It features a flexible, small-diameter tube that can be navigated through the vascular system to deliver medications or contrast agents directly to targeted areas.

It is supplied as a sterile, single-use device. The device received FDA 510(k) clearance (K895932) on January 4, 1990, following a traditional review by the Cardiovascular advisory committee. It is classified as Class II with special controls and is manufactured by Peripheral Systems Group in Mountain View, California.

Other devices from Peripheral Systems Group

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Questions

AI-generated answers, 6 Oct 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 PSG(TM) EDM(TM) Infusion Catheter used for?

    It is a specialized percutaneous catheter designed for the infusion of therapeutic agents into the venous system, allowing delivery of medications or contrast agents directly to targeted areas via navigation through the vascular system.

  • How is the PSG(TM) EDM(TM) Infusion Catheter supplied and is it reusable?

    The device is supplied as a sterile, single-use catheter, meaning it is intended for one procedure only and must be discarded after use to prevent infection and ensure patient safety.

  • What regulatory clearance does the PSG(TM) EDM(TM) Infusion Catheter have?

    It received FDA 510(k) clearance under submission K895932 on January 4, 1990, following a traditional review by the Cardiovascular advisory committee, and is classified as a Class II device with special controls.