OPTION ELITE VENA CAVA FILTER SYSTEM
FDA 510(k) clearance K133243 · decided 2013-12-17
Clearance details
- K-number
- K133243
- Device name
- OPTION ELITE VENA CAVA FILTER SYSTEM
- Applicant
- Rex Medical, L.P.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-22
- Decision date
- 2013-12-17
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DTK
- Device class
- 2
- Regulation number
- 870.3375
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option recall (Z-0589-2026) | Argon Medical Devices, Inc | 2025-11-24 |
| Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable recall (Z-2239-2023) | Argon Medical Devices, Inc | 2023-07-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Closer Vascular Sealing System (VSS) (P150022/S007) | Rex Medical, L.P. | 2018-10-01 |
| Closer Vascular Sealing System (VSS) (P150022/S005) | Rex Medical, L.P. | 2018-07-10 |
| Closer Vascular Sealing System (P150022/S004) | Rex Medical, L.P. | 2018-02-07 |
| Closer Vascular Sealing System (VSS) (P150022/S003) | Rex Medical, L.P. | 2018-01-31 |
| CLOSER VASCULAR SEALING SYSTEM (P150022/S002) | Rex Medical, L.P. | 2016-11-10 |
| CLOSER VASCULAR SEALING SYSTEM (P150022/S001) | Rex Medical, L.P. | 2016-06-10 |
| CLOSER VASCULAR SEALING SYSTEM (P150022) | Rex Medical, L.P. | 2016-02-12 |