The following data is part of a premarket notification filed by Rex Medical, L.p. with the FDA for Cleanerxt Rotational Thrombectomy System, Cleaner15 Rotational Thrombectomy System.
| Device ID | K141617 |
| 510k Number | K141617 |
| Device Name: | CLEANERXT ROTATIONAL THROMBECTOMY SYSTEM, CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | REX MEDICAL, L.P. 55 NORTHERN BOULBEVARD Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk REX MEDICAL, L.P. 55 NORTHERN BOULBEVARD Great Neck, NY 11021 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-17 |
| Decision Date | 2014-11-14 |
| Summary: | summary |