The following data is part of a premarket notification filed by Rex Medical with the FDA for Cleaner Rotational Thrombectomy System.
| Device ID | K120346 |
| 510k Number | K120346 |
| Device Name: | CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
| 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 | 2012-02-03 |
| Decision Date | 2012-06-01 |
| Summary: | summary |