The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/x Ivus Imaging Catheter, Model 85700.
| Device ID | K073473 |
| 510k Number | K073473 |
| Device Name: | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Arlene Blades |
| Correspondent | Arlene Blades 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 | 2007-12-11 |
| Decision Date | 2008-01-14 |
| Summary: | summary |