The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859xx; Volcano Vh-ivus System, Model 8049xx-001.
| Device ID | K051337 |
| 510k Number | K051337 |
| Device Name: | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 2870 KILGORE ROAD Rancho Cordova, CA 95670 |
| Contact | Lorry Huffman |
| Correspondent | Lorry Huffman VOLCANO CORPORATION 2870 KILGORE ROAD 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 | 2005-05-23 |
| Decision Date | 2005-08-18 |
| Summary: | summary |