The following data is part of a premarket notification filed by Rex Medical, Lp with the FDA for Option (tm) Elite Vena Cava Filter 100cm System.
| Device ID | K143405 |
| 510k Number | K143405 |
| Device Name: | Option (TM) ELITE Vena Cava Filter 100cm System |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | REX MEDICAL, LP 555 North Ln Suite 5035 Conshohocken, PA 19428 |
| Contact | Erich Bressler |
| Correspondent | Susan D Goldsstein-falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-04-16 |
| Summary: | summary |