Pinnacle Multi-Programmable Pacing Sys
510(k) K853771
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853771 | Date15 Jul 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXY
- 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
The Pinnacle Multi-Programmable Pacing System is an implantable pacemaker pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. It is classified as a Class III medical device and is intended for patients requiring cardiac pacing to correct bradycardia or other conduction disorders.
This system is implanted surgically and is intended for single-patient use. It operates within MRI-safe parameters as defined by its specifications and is regulated under FDA 510(k) clearance (K853771) with a decision of Substantially Equivalent. The device is supplied sterile and requires proper storage to maintain functionality, adhering to standard implantable device protocols.
Other devices from Cardio-Pace Medical, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of heart conditions is the Pinnacle Multi-Programmable Pacing System designed to treat, and how does it work?
The Pinnacle Multi-Programmable Pacing System is intended for patients with bradycardia or conduction disorders, which cause an abnormally slow heart rate or improper electrical signaling in the heart. It works by delivering precise electrical impulses to the heart muscle through surgical implantation, helping to regulate and maintain a normal heart rhythm.
Is the Pinnacle Multi-Programmable Pacing System intended for reuse, or is it meant for single-patient use only?
The device is explicitly designed for single-patient use only, meaning it is not intended to be reused after implantation in one individual. This aligns with standard practices for implantable pacemakers to ensure patient safety and sterility.
How should the Pinnacle Multi-Programmable Pacing System be stored to maintain its functionality and sterility?
The device is supplied sterile and must be stored according to standard protocols for implantable medical devices. Proper storage conditions—such as maintaining dryness, avoiding extreme temperatures, and protecting from physical damage—are critical to preserve its functionality and sterility before implantation.
Can this pacemaker be used in patients who require MRI scans, and if so, what safety considerations apply?
Yes, the Pinnacle Multi-Programmable Pacing System operates within MRI-safe parameters as defined by its specifications. However, MRI use should always follow the manufacturer’s guidelines and clinical protocols to ensure patient safety, as specific settings and precautions may apply depending on the MRI machine and scan parameters.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its safety and effectiveness?
The device received FDA clearance through a 510(k) submission, classified as *Substantially Equivalent* (SESE) under the Traditional review pathway. This means the FDA determined that the Pinnacle system is at least as safe and effective as a legally marketed predicate device (an earlier pacemaker model) and meets applicable regulatory standards for implantable pacemakers.