Pulse Generator Model 688

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

510(k) Number

K833519 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Erectaid

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See all devices from Burditt & Calkins-Siemens-Elema →

• What is the primary purpose of the Pulse Generator Model 688, and how does it function in a clinical setting?

  The Pulse Generator Model 688 is an implantable pacemaker pulse-generator designed to regulate abnormal cardiac rhythms by delivering timed electrical impulses to the heart. It is surgically implanted to ensure consistent pacing when the patient’s natural electrical conduction system fails, helping maintain a stable heart rate and rhythm for patients with bradycardia or other pacing-dependent conditions.

• Is the Pulse Generator Model 688 intended for reuse, or is it meant to be implanted as a single-use device?

  The Pulse Generator Model 688 is explicitly supplied sterile and intended for single-use implantation. Once implanted, it is not designed for removal or reuse, aligning with standard practices for implantable pacemaker pulse-generators to ensure patient safety and sterility.

• What regulatory pathway was followed for FDA clearance of this device, and when was the decision made?

  The Pulse Generator Model 688 received FDA 510(k) clearance under the traditional review pathway, with a decision date of January 30, 1984. The submission was classified under the Cardiovascular (CV) advisory committee and was deemed *Substantially Equivalent* (SESE) to a predicate device, as indicated in the regulatory records.

• Are there any known compatibility considerations for this device, such as MRI use, that clinicians should be aware of?

  The Pulse Generator Model 688 does not have documented MRI compatibility in the available data. Clinicians should exercise caution when considering MRI procedures for patients with this device, as implantable pacemakers are generally contraindicated in MRI environments due to potential electromagnetic interference risks.