Inquiry AFocus II Diagnostic Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K053582 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 AFocus II Diagnostic Catheter is a catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. It is designed for use in mapping procedures within the heart.
The device is supplied by Irvine Biomedical, Inc. and has FDA 510(k) clearance with the product code DRF. It is available in model number IBI-87008 and is in commercial distribution.
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 AFOCUS II DIAGNOSTIC CATHETER - Innolitics, Inquiry™ AFocus II™ - BEUDAMED, AccessGUDID - DEVICE: Inquiry™ AFocus II™ (05414734309929), Inquiry Afocus, Inquiry Afocus Ii and Inquiry Optima Steerable ..., PDF MAR 20Db /(O - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053582 | Class II | Active |
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Manufacturer
- Manufacturer
- Irvine Biomedical, Inc.
Sources (1)
- FDA 510(k) K053582 24 fields · synced Sep 26, 2026