The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Sync-rx System.
| Device ID | K132558 |
| 510k Number | K132558 |
| Device Name: | SYNC-RX SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2013-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225012830 | K132558 | 000 |
| 00845225012441 | K132558 | 000 |
| 00845225012434 | K132558 | 000 |