The following data is part of a premarket notification filed by Irvine Biomedical,inc.(ibi) with the FDA for Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter.
| Device ID | K070011 |
| 510k Number | K070011 |
| Device Name: | IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | IRVINE BIOMEDICAL,INC.(IBI) 2375 MORSE AVE. Irvine, CA 92614 |
| Contact | Rohit Patel |
| Correspondent | Rohit Patel IRVINE BIOMEDICAL,INC.(IBI) 2375 MORSE AVE. Irvine, CA 92614 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-03-20 |
| Summary: | summary |