The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Visions Pv .035 Digital Ivus Catheter.
| Device ID | K153094 |
| 510k Number | K153094 |
| Device Name: | Visions PV .035 Digital IVUS Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Neeta Sharma |
| Correspondent | Neeta Sharma Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2015-12-31 |