The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Core Control Pad, Accessory To The Volcano S5/s5i Intravascular Ultrasound Imaging & Pressure Systems.
| Device ID | K140291 |
| 510k Number | K140291 |
| Device Name: | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
| Contact | Marcus Garcia |
| Correspondent | Marcus Garcia VOLCANO CORPORATION 1 FORTUNE DR Billerica, MA 01821 |
| Product Code | IYO |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSK |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-05 |
| Decision Date | 2014-03-07 |
| Summary: | summary |