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Wedge Pressure Catheter

by Plasmedics, Inc.

510(k) K830604

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 NumberK830604 Date18 Jul 1983ClearedStatusActive

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  • Withdrawn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
DYG
Device Class
Class II
Regulation
21 CFR Part 870.1240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Wedge Pressure Catheter is a flow-directed catheter used to measure pressures in the right heart, including central venous pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary artery wedge pressure. It is designed for sampling blood for oxygen levels and is commonly employed in cardiovascular procedures.

The device is supplied as a single-use catheter, with available sizes of 5, 6, and 7Fr. It is radiopaque and includes markings every 10cm from the tip for precise positioning. The catheter is not MRI-safe and should be stored according to manufacturer guidelines. It is cleared by the FDA under 510(k) K830604.

Other devices from Plasmedics, Inc.

Questions

AI-generated answers, 26 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 Wedge Pressure Catheter used for?

    This device is a flow-directed catheter used to measure pressures in the right heart, including central venous pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary artery wedge pressure.

  • What sizes are available for this catheter?

    The device is available in three sizes: 5, 6, and 7 French (Fr).

  • Is the catheter radiopaque and how is it marked?

    Yes, the catheter is radiopaque and includes markings every 10cm from the tip to assist with precise positioning.

  • Is the catheter intended for single use?

    The device is supplied as a single-use catheter.

  • What are the storage requirements for this device?

    The catheter should be stored according to the manufacturer's guidelines.