PacePath Model 819
by Pacesetter Systems 510(k)
Active
510(k) K801417
Overview
The PacePath Model 819 is a Permanent Pacemaker Electrode, designed to provide electrical stimulation for cardiac pacing. It is intended for implantation within the heart to regulate abnormal heart rhythms by delivering timed electrical impulses to the myocardium, ensuring proper cardiac function in patients with bradycardia or conduction system disorders.
This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. It is classified as a Class III medical device under FDA regulations and has received FDA 510K clearance as substantially equivalent to a predicate device. The electrode is available in various lead configurations and must be handled using aseptic techniques prior to implantation, adhering to standard sterile surgical protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801417 | Date23 Oct 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Pacesetter Systems
Questions
What types of heart conditions is the PacePath Model 819 designed to address, and how does it work?
The PacePath Model 819 is designed to address bradycardia and conduction system disorders by regulating abnormal heart rhythms. It achieves this through timed electrical stimulation delivered directly to the myocardium (heart muscle) via implantation within the heart. The device ensures proper cardiac function by pacing the heart when its natural rhythm is too slow or irregular.
Is the PacePath Model 819 intended for reuse, or is it meant to be used only once per patient?
The PacePath Model 819 is explicitly intended for single-use implantation only. It is supplied sterile and must be handled using aseptic techniques prior to use, adhering to standard sterile surgical protocols to ensure patient safety.
What lead configurations are available for the PacePath Model 819, and how are they selected?
The PacePath Model 819 is available in various lead configurations, though the exact options are not detailed in the provided data. Selection of the appropriate lead configuration depends on the patient’s clinical needs, anatomical requirements, and the specific pacing requirements (e.g., atrial, ventricular, or biventricular pacing). Consultation with a cardiologist or electrophysiologist is recommended to determine the best fit.
How should the PacePath Model 819 be stored before use, and what precautions should be taken?
While specific storage instructions are not provided, the device is sterile and intended for surgical implantation. It should be stored in a clean, dry environment, protected from contamination, and handled using aseptic techniques. Follow manufacturer guidelines for packaging integrity and expiration dates to ensure sterility and functionality before use.
What regulatory pathway was followed for FDA clearance of the PacePath Model 819, and which committee reviewed it?
The PacePath Model 819 received FDA 510(k) clearance under the Traditional pathway, determined to be substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations.