The following data is part of a premarket notification filed by Atheromed Inc with the FDA for Phoenix 5f Tracking Atherectomy Catheter, Phoenix 6f Tracking Atherectomy Catheter, Phoenix 7d Deflecting Atherectomy Ca.
| Device ID | K132682 |
| 510k Number | K132682 |
| Device Name: | PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | ATHEROMED INC 1455 ADAMS DRIVE SUITE 1110 Menlo Park, CA 94025 |
| Contact | Elisa Hebb |
| Correspondent | Elisa Hebb ATHEROMED INC 1455 ADAMS DRIVE SUITE 1110 Menlo Park, CA 94025 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-28 |
| Decision Date | 2014-01-17 |
| Summary: | summary |