The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Valet Micro Catheter.
| Device ID | K112035 |
| 510k Number | K112035 |
| Device Name: | VALET MICRO CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Contact | Lisa Quaglia |
| Correspondent | Lisa 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 | 2011-07-15 |
| Decision Date | 2012-01-05 |
| Summary: | summary |