The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Visions Pv.014p Rx Digital Ivus Catheter.
| Device ID | K152829 |
| 510k Number | K152829 |
| Device Name: | Visions PV.014P RX Digital IVUS Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Volcano Corporation 3721 Valley Centre Drive, Suite 500 San Diego, CA 92130 |
| Contact | Mary Stanners |
| Correspondent | Mary Stanners Volcano Corporation 3721 Valley Centre Drive, Suite 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 | 2015-09-29 |
| Decision Date | 2015-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002848 | K152829 | 000 |
| 00845225002428 | K152829 | 000 |