Inquiry Optima Plus Steerable Electrophysiology Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060757 FDA 510(k)
- FDA Product Code
- DRF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1220 FDA 510(k)
- Regulation Number
- 870.1220 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inquiry Optima Plus Steerable Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. It is designed to map the atrial regions of the heart.
The catheter is supplied with a deflectable shaft steering mechanism and a distal end with a variable loop diameter, allowing for selection of diameters within a specific range. The device is regulated under product code DRF and regulation number 870.1220, with authorizations including FDA 510K clearance.
Frequently asked questions
What is the Inquiry Optima Plus Steerable Electrophysiology Catheter used for?
The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies, specifically to map the atrial regions of the heart.
How is the catheter supplied?
The catheter is supplied with a deflectable shaft steering mechanism and a distal end with a variable loop diameter, allowing for selection of diameters within a specific range.
Is the catheter regulated by any authorities?
Yes, the device is regulated under product code DRF and regulation number 870.1220, with authorizations including FDA 510K clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER by IRVINE ..., PDF Instructions for Use Reprocessed Inquiry™ Optima™ & Inquiry™ Optima ..., Inquiry EP catheter - Stryker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060757 | Class II | Active |
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Manufacturer
- Manufacturer
- Irvine Biomedical, Inc.
Sources (1)
- FDA 510(k) K060757 24 fields · synced Sep 26, 2026