Durapulse P101 Coated Pulse Generator

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

Full name

Cario-Pace Durapulse P101 Coated Pulse Generator

510(k) Number

K853425 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pinnacle Multi-Programmable Pacing Sys

  Class III

  FDA 510(k) K853771 Active Cleared 15 Jul 1986

• Pinnacle SR 8701 Unipolar & 8702 Bipolar

  Class III

  FDA 510(k) K870142 Active Cleared 22 Apr 1987

• What is the primary purpose of the CARIO-PACE DURAPULSE P101 Coated Pulse Generator in clinical practice?

  The CARIO-PACE DURAPULSE P101 Coated Pulse Generator is designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle when needed. It is intended for patients requiring cardiac pacing to maintain proper heart function, ensuring consistent contractions of the heart when natural electrical signals are insufficient.

• How is the CARIO-PACE DURAPULSE P101 supplied, and what precautions should be taken during handling?

  The device is supplied sterile and must be handled in a controlled clinical environment, adhering to standard protocols for implantable medical devices. Since it is intended for single-use within the body, it should only be opened and used in sterile conditions to prevent contamination before implantation.

• Is this device reusable, or is it meant to be implanted permanently and replaced later if needed?

  The CARIO-PACE DURAPULSE P101 is intended for single-use within the body, meaning it is designed to be implanted once. However, like all implantable pacemakers, it may require replacement over time due to battery depletion or other factors, following standard clinical replacement protocols.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The device received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type, with a substantially equivalent determination (SESE). This means the FDA reviewed it against a legally marketed predicate device and determined it is as safe and effective for its intended use. Clinicians can rely on this clearance as evidence of regulatory scrutiny for its safety and performance in cardiac pacing applications.

• What medical specialty is primarily responsible for the use and management of this device?

  The CARIO-PACE DURAPULSE P101 falls under the Cardiovascular medical specialty, as indicated by its regulatory classification. This device is intended for use by cardiologists, electrophysiologists, or other specialists trained in implantable cardiac devices to diagnose and treat abnormal heart rhythms through pacing therapy.