The following data is part of a premarket notification filed by Atheromed Inc with the FDA for 1.8 Mm Phoenix Atherectomy Catheter, 2.2 Mm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip.
| Device ID | K140944 |
| 510k Number | K140944 |
| Device Name: | 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | ATHEROMED INC 1455 ADAMS DRIVE SUITE 1120 Menlo Park, CA 94025 |
| Contact | Jean Chang |
| Correspondent | Jean Chang 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 | 2014-04-14 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225003562 | K140944 | 000 |
| 00845225003548 | K140944 | 000 |
| 00845225003494 | K140944 | 000 |
| 00845225003470 | K140944 | 000 |