The following data is part of a premarket notification filed by Fox Hollow Technologies with the FDA for Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406.
| Device ID | K024243 |
| 510k Number | K024243 |
| Device Name: | REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | FOX HOLLOW TECHNOLOGIES 300 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Suzon Lommel |
| Correspondent | Suzon Lommel FOX HOLLOW TECHNOLOGIES 300 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-06-20 |
| Summary: | summary |