Advisor FL Sensor Enabled Circular Mapping Catheter
by Innovative Health LLC 510(k)
Active
510(k) K181458
Overview
This device is a Catheter, Recording, Electrode, Reprocessed, classified as a Class II medical device under FDA regulations. It is designed for intracardiac signal recording and cardiac stimulation during diagnostic electrophysiology studies, featuring sensor-enabled technology for enhanced mapping capabilities. The catheter is steerable and constructed with thermoplastic elastomer material and noble metal electrodes, enabling precise manipulation and signal acquisition within the cardiovascular system.
The Advisor FL Sensor Enabled Circular Mapping Catheter is supplied as a reprocessed, single-use device intended for use in electrophysiology laboratories. It is intended for MRI Conditional use (MRI Conditional per manufacturer’s instructions) and is regulated under FDA 510(k) clearance (K181458). The device is available in multiple reference codes (e.g., 3011276773, 3003076831) and must be stored according to reprocessing guidelines to maintain sterility and performance. Authorized for cardiovascular applications, it adheres to FDA’s traditional 510(k) review pathway.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181458 | Date27 Oct 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
- 510(k) Number
- FDA Product Code
- NLH
- FDA applicant
- Innovative Health, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Innovative Health, LLC.
Questions
What is the primary use of the Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter?
This catheter is designed for intracardiac signal recording and cardiac stimulation during diagnostic electrophysiology studies. Its sensor-enabled technology enhances mapping capabilities, allowing clinicians to achieve precise manipulation and signal acquisition within the cardiovascular system. This is particularly useful in identifying arrhythmias and guiding ablation procedures.
Is this device single-use or reusable, and how should it be stored?
The Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter is supplied as a reprocessed, single-use device. To maintain sterility and performance, it must be stored strictly according to the manufacturer’s reprocessing guidelines. These guidelines ensure the device remains safe and effective for its intended use in electrophysiology laboratories.
What materials is the catheter constructed from, and why does this matter?
The catheter is constructed from thermoplastic elastomer material with noble metal electrodes. Thermoplastic elastomers provide flexibility and durability, which are critical for precise navigation within the cardiovascular system. Noble metal electrodes ensure reliable signal acquisition and stability during electrophysiology procedures, reducing the risk of signal degradation or interference.
What reference codes or models are available for this catheter?
This device is available in multiple reference codes, including 3011276773, 3003076831, 1000138054, 3011610434, and others. These codes correspond to different configurations or batches of the reprocessed catheter, ensuring compatibility with various clinical settings and patient needs. Always verify the specific reference code against the manufacturer’s documentation to confirm suitability for your procedure.
Can this catheter be used in MRI environments, and what precautions should be taken?
Yes, the Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter is designed for MRI Conditional use, provided it is used strictly according to the manufacturer’s instructions. MRI Conditional status means it is safe for use in specific MRI environments under controlled conditions. Clinicians must follow the manufacturer’s guidelines to avoid compromising the device’s performance or patient safety, such as adhering to MRI system compatibility requirements and avoiding exposure to high magnetic fields outside specified limits.