The following data is part of a premarket notification filed by Volcano Atheromed Inc. with the FDA for Phoenix Atherectomy System.
| Device ID | K182972 |
| 510k Number | K182972 |
| Device Name: | Phoenix Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Volcano AtheroMed Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 |
| Contact | Jean Chang |
| Correspondent | Jean Chang Volcano AtheroMed Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-26 |
| Decision Date | 2018-12-20 |
| Summary: | summary |