Skip to content

Catheter, Pacing/Monitoring

by Electro-Catheter Corp.

510(k) K772059

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 NumberK772059 Date15 Nov 1977ClearedStatusActive

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  • Withdrawn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, 27 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 Catheter, Pacing/Monitoring is a medical device designed for pacing and monitoring functions. It is classified under the product code DYG and is intended for cardiovascular applications.

This device is manufactured by Electro-Catheter Corp. and received FDA 510(k) clearance on November 15, 1977, with the K number K772059. The device is classified as Class II and is regulated under the regulation number 870.1240.

Other devices from Electro-Catheter Corp.

See all devices from Electro-Catheter Corp. →

Questions

AI-generated answers, 27 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 Catheter Pacing/Monitoring used for?

    The Catheter Pacing/Monitoring is designed for pacing and monitoring functions in cardiovascular applications. It is a Class II medical device that helps clinicians monitor and pace cardiac activity during procedures.

  • Is this catheter single-use or reusable?

    The device data does not specify whether this catheter is single-use or reusable. Clinicians should consult the manufacturer's instructions for use to determine the appropriate handling and disposal procedures for this specific device.

  • What regulatory approvals does this catheter have?

    This catheter received FDA 510(k) clearance on November 15, 1977, with K number K772059. It is classified as Class II under regulation number 870.1240 and is regulated by the Cardiovascular advisory committee.

  • What sizes and models of this catheter are available?

    The device data does not specify available sizes or models for this catheter. Clinicians should contact Electro-Catheter Corp. directly or consult the product catalog for specific size options and model variations that may be available.