The following data is part of a premarket notification filed by Philips Image Guided Therapy Corporation with the FDA for Verisight Intracardiac Echocardiography (ice) Catheter, Verisight Pro Ice Catheter.
| Device ID | K200812 |
| 510k Number | K200812 |
| Device Name: | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Philips Image Guided Therapy Corporation 3721 Valley Centre Drive., Suite 500 San Diego, CA 92130 |
| Contact | Rand Daoud |
| Correspondent | Rand Daoud Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225003036 | K200812 | 000 |
| 00845225003029 | K200812 | 000 |
| 00845225012854 | K200812 | 000 |