The following data is part of a premarket notification filed by Volcano Atheromed, Inc. with the FDA for 1.8mm X 149 Cm Phoenix Atherectomy Catheter, 2.2mm X 149 Cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip.
| Device ID | K143328 |
| 510k Number | K143328 |
| Device Name: | 1.8mm X 149 Cm Phoenix Atherectomy Catheter, 2.2mm X 149 Cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip |
| 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 | 2014-11-20 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002732 | K143328 | 000 |
| 00845225002725 | K143328 | 000 |
| 00845225002657 | K143328 | 000 |
| 00845225002640 | K143328 | 000 |
| 00845225003579 | K143328 | 000 |
| 00845225003555 | K143328 | 000 |
| 00845225003500 | K143328 | 000 |
| 00845225003487 | K143328 | 000 |