Telemetry Wand Model

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K855171 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What is the primary purpose of the Telemetry Wand Model from Cardiac Pacemakers, Inc. and where is it typically used?

  The Telemetry Wand Model is designed for wireless communication with implantable pacemaker pulse generators, enabling real-time monitoring of heart function and device performance without direct physical connections. It is intended for use in clinical settings like hospitals or cardiac care units where continuous cardiac monitoring is required.

• Is the Telemetry Wand Model a single-use or reusable device, and what does this mean for maintenance?

  The Telemetry Wand Model is supplied as a reusable medical instrument. This means it is designed for repeated use across multiple patients, but it requires proper cleaning, disinfection, and maintenance procedures to ensure reliability and safety between uses, as outlined in the manufacturer’s instructions.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The Telemetry Wand Model received FDA clearance through a 510(k) submission, classified under the Cardiovascular advisory committee (CV) and falls under the traditional clearance type. It is designated as a Class III device for telemetry applications in pacemaker systems, regulated under the code 870.3610.

• Are there any specific storage requirements mentioned for the Telemetry Wand Model?

  The provided data does not explicitly detail storage requirements such as temperature ranges or environmental conditions. However, as a reusable medical device, it should be stored in a clean, dry environment following the manufacturer’s guidelines to maintain functionality and prevent contamination.