The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Preview Forward-looking Ivus System.
| Device ID | K132659 |
| 510k Number | K132659 |
| Device Name: | VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Contact | Marcus Garcia |
| Correspondent | Marcus Garcia VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2013-09-27 |
| Summary: | summary |