The following data is part of a premarket notification filed by Volcano Atheromed Inc with the FDA for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System.
| Device ID | K172386 |
| 510k Number | K172386 |
| Device Name: | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Volcano AtheroMed Inc 1530 O'Brien Drive Suite A Menlo Park, CA 94025 |
| Contact | Jean Chnag |
| Correspondent | Jean Chnag 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 | 2017-08-08 |
| Decision Date | 2017-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002978 | K172386 | 000 |
| 00845225002961 | K172386 | 000 |