The following data is part of a premarket notification filed by Rex Medical, L.p. with the FDA for Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire.
| Device ID | K191419 |
| 510k Number | K191419 |
| Device Name: | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Rex Medical, L.P. 555 East North Lane, Suite 5035 Conshohocken, PA 19428 |
| Contact | Colin Valentis |
| Correspondent | Colin Valentis Rex Medical, L.P. 555 East North Lane, Suite 5035 Conshohocken, PA 19428 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-28 |
| Decision Date | 2019-09-12 |
| Summary: | summary |