The following data is part of a premarket notification filed by Volcano Therapeutics, Inc. with the FDA for Volcano Therapeutics, Inc. Volcano Ivus System.
| Device ID | K042188 |
| 510k Number | K042188 |
| Device Name: | VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO THERAPEUTICS, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | James Farnworth |
| Correspondent | James Farnworth VOLCANO THERAPEUTICS, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-12 |
| Decision Date | 2004-11-10 |
| Summary: | summary |