The following data is part of a premarket notification filed by Volcano Atheromed, Inc. with the FDA for 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System.
| Device ID | K211518 |
| 510k Number | K211518 |
| Device Name: | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm 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 | 2021-05-17 |
| Decision Date | 2021-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225003197 | K211518 | 000 |
| 00845225003180 | K211518 | 000 |
| 00845225003173 | K211518 | 000 |
| 00845225003166 | K211518 | 000 |
| 00845225003593 | K211518 | 000 |
| 00845225003531 | K211518 | 000 |
| 00845225003524 | K211518 | 000 |
| 00845225003463 | K211518 | 000 |