The following data is part of a premarket notification filed by Rex Medical Lp with the FDA for Option Elite Vena Cava Filter System.
| Device ID | K133243 |
| 510k Number | K133243 |
| Device Name: | OPTION ELITE VENA CAVA FILTER SYSTEM |
| Classification | Filter, Intravascular, Cardiovascular |
| 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 | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-22 |
| Decision Date | 2013-12-17 |
| Summary: | summary |