Diagnostic I Catheter
by Ep Technologies, Inc. 510(k)
Active
510(k) K940167
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940167 | Date2 Aug 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DRF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Diagnostic I Catheter is an electrode recording catheter designed for intracardiac electrophysiological studies. It facilitates the acquisition of precise electrical signals within the heart, enabling detailed mapping of cardiac activity. Constructed with radiopaque materials and insulated electrodes, it supports diagnostic procedures in cardiovascular electrophysiology. The catheter’s flexible and steerable design allows targeted positioning for accurate signal recording.
This catheter is supplied as a single-use, non-sterile device intended for use in controlled clinical settings. It is classified under FDA device class II (DRF product code) and holds a 510(k) clearance (K940167) for substantial equivalence. The device is not MRI-safe and must be stored according to manufacturer guidelines. Multiple registration numbers (e.g., 3008497357) reflect its regulatory filing under the U.S. Food and Drug Administration’s cardiovascular specialty category.
Other devices from Ep Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Diagnostic I Catheter used for?
The Diagnostic I Catheter is designed specifically for intracardiac electrophysiological studies. It allows clinicians to acquire detailed electrical signals within the heart, enabling precise mapping of cardiac activity. This is particularly useful in diagnosing arrhythmias and guiding interventions in cardiovascular electrophysiology.
Is the Diagnostic I Catheter sterile?
No, the Diagnostic I Catheter is supplied as a single-use, non-sterile device. It is intended for use in controlled clinical settings where sterility can be maintained through proper handling and preparation protocols before use.
Can the Diagnostic I Catheter be reused?
No, the Diagnostic I Catheter is designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise the integrity of the device and potentially affect diagnostic accuracy or patient safety.
What materials is the Diagnostic I Catheter made from?
The Diagnostic I Catheter is constructed with radiopaque materials and insulated electrodes. The radiopaque components allow for visibility under fluoroscopy during procedures, ensuring accurate catheter positioning within the heart.
How should the Diagnostic I Catheter be stored?
The Diagnostic I Catheter must be stored according to the manufacturer’s guidelines to maintain its functionality and integrity. Since it is non-sterile and single-use, storage should be in a clean, dry environment, protected from contamination and physical damage. Follow Ep Technologies’ specific instructions to ensure optimal performance.