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Pacel Flow Directed Pacing Catheter

by Daig Corp. 510(k)

Active United States

510(k) K914185

Overview

The Pacel Flow Directed Pacing Catheter is a temporary pacemaker electrode used for cardiac pacing procedures. It is designed to be flow-directed, allowing for placement in the heart's vasculature without the need for fluoroscopic guidance.

This single-use device is supplied sterile and is intended for temporary cardiac pacing applications. It is classified under product code LDF and has received FDA 510(k) clearance as substantially equivalent, with regulatory authorization number K914185. The device is manufactured by Daig Corp. and is available in various sizes as indicated by the multiple registration numbers provided.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914185 Date27 Jan 1992ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Pacel(Tm) Flow Directed Pacing Catheter
510(k) Number
FDA Product Code
LDF
Device Class
Class II
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Daig Corp.

See all devices from Daig Corp. →

Questions

  • What is the PACEL Flow Directed Pacing Catheter used for?

    The PACEL Flow Directed Pacing Catheter is a temporary pacemaker electrode designed for cardiac pacing procedures. It features a flow-directed design that allows for placement in the heart's vasculature without requiring fluoroscopic guidance.

  • Is the PACEL Flow Directed Pacing Catheter single-use or reusable?

    This device is designed for single-use only. It is supplied sterile and should not be reused to ensure patient safety and maintain device integrity.

  • What regulatory authorization does the PACEL Flow Directed Pacing Catheter have?

    The PACEL Flow Directed Pacing Catheter has received FDA 510(k) clearance as substantially equivalent with regulatory authorization number K914185. It is classified under product code LDF and is intended for temporary cardiac pacing applications.

  • What sizes and models of the PACEL Flow Directed Pacing Catheter are available?

    The device is available in various sizes as indicated by the multiple registration numbers provided. Each registration number corresponds to a specific size or model variation of the catheter to accommodate different clinical needs.