The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Inquiry Afocusii Diagnostic Catheter.
| Device ID | K101623 |
| 510k Number | K101623 |
| Device Name: | INQUIRY AFOCUSII DIAGNOSTIC CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ST. JUDE MEDICAL 2375 MORSE AVENUE Irvine, CA 92614 -6233 |
| Contact | Quynh Phuong Le |
| Correspondent | Quynh Phuong Le ST. JUDE MEDICAL 2375 MORSE AVENUE Irvine, CA 92614 -6233 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2010-08-13 |
| Summary: | summary |