The following data is part of a premarket notification filed by Rex Medical with the FDA for Cleaner Rotational Thrombectomy System (9 Mm X 65 Cm) And (9 Mm X 120 Cm).
| Device ID | K091029 |
| 510k Number | K091029 |
| Device Name: | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-10 |
| Decision Date | 2010-02-18 |
| Summary: | summary |