The following data is part of a premarket notification filed by Volcano Atheromed, Inc. with the FDA for 2.4mm X 127 Cm Phoenix Atherectomy Deflecting System.
| Device ID | K151145 |
| 510k Number | K151145 |
| Device Name: | 2.4mm X 127 Cm Phoenix Atherectomy Deflecting System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Volcano AtheroMed, Inc. 1455 Adams Drive, Suite 1120 Menlo Park, CA 94025 |
| Contact | Jean Chang |
| Correspondent | Jean Chang Volcano AtheroMed, Inc. 1455 Adams Drive, Suite 1120 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 | 2015-04-29 |
| Decision Date | 2015-05-26 |
| Summary: | summary |