Reprocessed Inquiry Steerable Diagnostic EP Catheter
by Innovative Health LLC 510(k)
Active
510(k) K203261
Overview
This device is a Catheter, Electrode Recording (FDA classification II), designed for electrophysiological studies. It features flexible, insulated construction with noble metal electrodes and a steerable tip for precise intracardiac manipulation, enabling accurate recording of cardiac signals and stimulation during diagnostic procedures.
The catheter is supplied as a single-use, reprocessed medical device, intended for use in electrophysiology labs under sterile conditions. It is compatible with MRI environments (as indicated by its FDA clearance under regulation 870.1220) and is available in multiple reference codes (e.g., 3008497357, 1000125147). Authorized by FDA 510(k) clearance (K203261), it adheres to cardiovascular medical specialty standards and is distributed by Innovative Health LLC.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203261 | Date5 Mar 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRF
- 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
Is this catheter designed for single-use or can it be reused after reprocessing?
This catheter is explicitly labeled as a single-use, reprocessed medical device. It is intended for use in electrophysiology labs after undergoing reprocessing by the manufacturer, Innovative Health LLC, ensuring compliance with regulatory standards for reuse.
What types of cardiac signals can this catheter record, and why is the steerable tip important?
The catheter is designed for electrophysiological studies, meaning it records intracardiac electrical signals (e.g., atrial/ventricular activity) and allows for stimulation mapping. The steerable tip enables precise intracardiac manipulation, improving accuracy during diagnostic procedures by allowing navigation through complex cardiac anatomy.
Are there multiple sizes or models available, and how do I identify the correct one for my procedure?
This device is available in multiple reference codes (e.g., 3008497357, 1000125147), which correspond to different catheter configurations or lengths. While the data does not specify exact sizes, the product codes (e.g., DRF) and registration numbers indicate variability in design. Always verify the specific model number or code with Innovative Health LLC to ensure compatibility with your procedure requirements.
How should this catheter be stored, and is it compatible with MRI environments?
The catheter is intended for use in sterile conditions, so storage should follow standard sterile medical device protocols (e.g., sealed packaging, protected from contamination). It is MRI-compatible, as confirmed by its FDA clearance under regulation 870.1220, meaning it can be safely used in MRI environments without interference.
What regulatory pathway was followed for this reprocessed catheter, and who should I contact for further details?
This device was authorized via an FDA 510(k) clearance (K203261), classified as substantially equivalent under the Cardiovascular specialty. For inquiries about reprocessing standards, compliance, or specific model details, contact Rick Ferreira at Innovative Health LLC (address: 1435 N. Hayden Rd., Suite 100, Scottsdale, AZ 85257).