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Endocard. Pacing Lead Std. Length PL202

by Daig Corp. 510(k)

Active United States

510(k) K800350

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800350 Date28 May 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Endocardial Pacing Lead Standard Length PL202 is a permanent pacemaker electrode, designed for implantation within the heart to deliver electrical stimulation. It facilitates cardiac pacing by transmitting low-energy pulses to regulate abnormal heart rhythms, ensuring proper electrical conduction in patients with bradycardia or conduction disorders.

This lead is intended for use in cardiac electrophysiology procedures, supplied sterile and intended for single-use implantation. It is classified as a Class III device under FDA regulations and has received FDA 510K clearance as substantially equivalent to a predicate device. The PL202 is supplied in a sterile package and must be handled under aseptic conditions prior to implantation, adhering to standard sterile field protocols.

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