Skip to content

Maestro Models 115, 118, 215, and 218 Pacemakers

by Cardiac Control Systems, Inc.

510(k) K880326

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 NumberK880326 Date11 Apr 1988ClearedStatusActive

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  • Withdrawn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
Maestro(R) Models 115, 118, 215 and 218 Pacemakers
510(k) Number
FDA Product Code
DXY
Models / Variants
Device Class
Class III
Regulation
21 CFR Part 870.3610
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 Maestro Models 115, 118, 215, and 218 are implantable pacemaker pulse-generators designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when needed. These devices are classified as Class III medical devices under FDA regulations and fall under the nomenclature of an implantable pacemaker pulse-generator, ensuring precise cardiac pacing for patients with bradycardia or conduction disorders.

These pacemakers are intended for surgical implantation and are supplied sterile for single-use. They are regulated under FDA 510(k) clearance with a traditional review pathway, classified under the product code DXY and regulation number 870.3610. Each model number (115, 118, 215, 218) corresponds to a distinct device variant, with specifications and features tailored for specific clinical applications. Storage and handling must comply with sterile medical device protocols.

Other devices from Cardiac Control Systems, Inc.

See all devices from Cardiac Control Systems, Inc. →