Inquiry AFocusII Diagnostic Catheter
510(k) K101623
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101623 | Date13 Aug 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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 Inquiry AFocusII Diagnostic Catheter is a steerable electrophysiology catheter designed for recording intracardiac electrical signals and facilitating cardiac stimulation during diagnostic electrophysiological studies. It is classified as an electrode recording catheter or probe, enabling precise mapping of atrial regions within the heart. The device incorporates a flexible, maneuverable design to enhance navigational accuracy during intracardiac procedures.
This catheter is intended for single-use in controlled clinical settings, such as electrophysiology labs, where sterility and precision are critical. It is not MRI-safe and must be handled according to manufacturer guidelines. Available in various configurations (as referenced by FEI numbers), the device requires proper storage under sterile conditions to maintain integrity. Its regulatory status includes FDA 510(k) clearance (K101623) under the Cardiovascular advisory committee, classified as a Class II device under regulation number 870.1220.
Other devices from St. Jude Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Inquiry AFocusII Diagnostic Catheter used for?
The Inquiry AFocusII Diagnostic Catheter is specifically designed for recording intracardiac electrical signals and facilitating cardiac stimulation during diagnostic electrophysiological (EP) studies. Its flexible, maneuverable design allows for precise mapping of atrial regions within the heart, making it ideal for procedures requiring detailed electrical activity assessment.
Is the Inquiry AFocusII Diagnostic Catheter single-use or reusable?
The Inquiry AFocusII Diagnostic Catheter is intended for single-use only in controlled clinical settings, such as electrophysiology labs. This ensures sterility and precision during procedures, reducing the risk of contamination or cross-infection between patients.
What configurations or models are available for the Inquiry AFocusII Diagnostic Catheter?
The Inquiry AFocusII Diagnostic Catheter is available in multiple configurations, each identified by a unique FEI number. These include models like 3001236763, 3008497357, 1000125147, and others, allowing clinicians to select the appropriate catheter based on procedural requirements and anatomical considerations.
How should the Inquiry AFocusII Diagnostic Catheter be stored to maintain integrity?
The catheter must be stored under sterile conditions to preserve its integrity and functionality. Improper storage—such as exposure to moisture, extreme temperatures, or contamination—can compromise sterility and performance. Follow the manufacturer’s guidelines for packaging and storage to ensure readiness for use in electrophysiology labs.
Is the Inquiry AFocusII Diagnostic Catheter MRI-safe?
The Inquiry AFocusII Diagnostic Catheter is not MRI-safe. It should never be used or placed near MRI equipment, as this could pose significant safety risks to patients and operators. Always verify compatibility with imaging modalities before use in clinical settings.