The following data is part of a premarket notification filed by Volcano Corporation with the FDA for S5 Intravascular Ultrasound Imaging And Pressure Systems, S5i Intravascular Ultrasound Imaging And Pressure Systems, Core Precision Guided Therapy System, Core Mobile Precision Guided Therapy System.
| Device ID | K173860 |
| 510k Number | K173860 |
| Device Name: | S5 Intravascular Ultrasound Imaging And Pressure Systems, S5i Intravascular Ultrasound Imaging And Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Nora York |
| Correspondent | Kimberly Simon Volcano Corporation 3721 Valley Centre Drive, Suite 500 San Diego, CA 92130 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-04-11 |
| Summary: | summary |