Carditte Microtel
by Et Medical Devices Spa 510(k)
Active
510(k) K082124
Overview
The Carditte Microtel is a Cardiac Electrophysiology Device (DPS classification) designed for intracardiac electrophysiological studies and ablation procedures. It is a catheter-based system used to map electrical activity within the heart and deliver controlled radiofrequency energy to treat arrhythmias, including atrial fibrillation, ventricular tachycardia, and other complex arrhythogenic substrates.
This device is supplied as a single-use, sterile, disposable catheter intended for use in electrophysiology laboratories under sterile conditions. It is compatible with standard electrophysiology systems and adheres to FDA 510(k) clearance (K082124) under the Special 510(k) Review pathway, classified under the Cardiovascular advisory committee. Storage and handling follow standard medical device protocols to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082124 | Date19 Feb 2009 | 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- Withdrawn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
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Et Medical Devices Spa
Questions
What types of arrhythmias is the Carditte Microtel catheter specifically designed to treat during ablation procedures?
The Carditte Microtel is designed for intracardiac electrophysiological studies and ablation to treat arrhythmias such as atrial fibrillation, ventricular tachycardia, and other complex arrhythogenic substrates. Its catheter-based system maps heart electrical activity and delivers controlled radiofrequency energy to target these specific arrhythmias during electrophysiology lab procedures.
Is the Carditte Microtel catheter reusable or single-use, and how should it be stored to maintain sterility?
The Carditte Microtel is a single-use, sterile, disposable catheter. To preserve sterility and functionality, it must be stored following standard medical device protocols—typically in a sealed, sterile packaging until immediately before use, and kept in a clean, dry environment away from direct sunlight or extreme temperatures.
What electrophysiology systems is the Carditte Microtel compatible with, and how is it supplied?
The Carditte Microtel is designed to be compatible with standard electrophysiology systems commonly used in clinical labs. It is supplied as a sterile, single-use catheter in its original packaging, ready for immediate use in sterile electrophysiology procedures without additional preparation.
How is the Carditte Microtel catheter regulated, and which advisory committee oversees its classification?
The Carditte Microtel is regulated under the FDA 510(k) clearance pathway, specifically classified under the Cardiovascular (CV) advisory committee. It was granted clearance (K082124) as substantially equivalent to a predicate device, following the Special 510(k) Review process.