The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano S5i Intravascular Ultracound Imaging And Pressure System.
| Device ID | K113486 |
| 510k Number | K113486 |
| Device Name: | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Jwala Jawharkar |
| Correspondent | Jwala Jawharkar VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-23 |
| Decision Date | 2012-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225012809 | K113486 | 000 |
| 00845225012748 | K113486 | 000 |
| 00845225012670 | K113486 | 000 |
| 00845225012571 | K113486 | 000 |
| 00845225012076 | K113486 | 000 |
| 00845225010300 | K113486 | 000 |
| 00845225010256 | K113486 | 000 |
| 00845225010096 | K113486 | 000 |