The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Inquiry Afocus Ii Diagnostic Catheter.
| Device ID | K053582 |
| 510k Number | K053582 |
| Device Name: | INQUIRY AFOCUS II DIAGNOSTIC CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine, CA 92614 |
| Contact | Elvia Zavala |
| Correspondent | Elvia Zavala IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine, CA 92614 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-03-21 |
| Summary: | summary |