The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Visions Pv .018 Digital Ivus Catheter.
| Device ID | K150442 |
| 510k Number | K150442 |
| Device Name: | Volcano Visions PV .018 Digital IVUS Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Mary Stanners |
| Correspondent | Mary Stanners VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-20 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00184360000037 | K150442 | 000 |