The following data is part of a premarket notification filed by Rex Medical Lp with the FDA for Cleaner Rotational Thrombectomy System.
Device ID | K060904 |
510k Number | K060904 |
Device Name: | CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
Classification | Catheter, Peripheral, Atherectomy |
Applicant | REX MEDICAL LP 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk REX MEDICAL LP 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Product Code | MCW |
CFR Regulation Number | 870.4875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-03 |
Decision Date | 2006-04-28 |
Summary: | summary |