The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Preview Forward-looking Ivus Catheter And Laptop System; Preview Catheter Model 87000; Pimf Model 87-pimf; Laptop System.
| Device ID | K122826 |
| 510k Number | K122826 |
| Device Name: | PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Contact | Lida Quaglia |
| Correspondent | Lida Quaglia VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-14 |
| Decision Date | 2013-04-24 |
| Summary: | summary |