The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Visions Pv .035 Ditital Ivus Catheter.
| Device ID | K121273 |
| 510k Number | K121273 |
| Device Name: | VISIONS PV .035 DITITAL IVUS CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Marilyn Pourazar |
| Correspondent | Marilyn Pourazar 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-27 |
| Decision Date | 2012-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002598 | K121273 | 000 |
| 00845225002596 | K121273 | 000 |