The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Visions Pv 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900.
| Device ID | K071660 |
| 510k Number | K071660 |
| Device Name: | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Jennifer Motto |
| Correspondent | Jennifer Motto VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-18 |
| Decision Date | 2007-08-31 |
| Summary: | summary |