Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter
FDA 510(k) clearance K233680 · decided 2024-01-18
Clearance details
- K-number
- K233680
- Device name
- Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter
- Applicant
- William Cook Europe Aps
- Decision
- Substantially Equivalent
- Date received
- 2023-11-16
- Decision date
- 2024-01-18
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- DTK
- Device class
- 2
- Regulation number
- 870.3375
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bjaeverskov, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith Dissection Endovascular System (ZDEG/ZDES) (P180001/S018) | William Cook Europe Aps | 2026-08-04 |
| Zenith Fenestrated AAA Endovascular Graft (P180001/S017) | William Cook Europe Aps | 2026-05-21 |
| Zenith Dissection Endovascular System (P180001/S016) | William Cook Europe Aps | 2026-05-08 |
| Zenith Dissection Endovascular System (P180001/S015) | William Cook Europe Aps | 2025-05-19 |
| Zenith Dissection Endovascular System (P180001/S014) | William Cook Europe Aps | 2024-07-19 |
| Zenith Dissection Endovascular System (P180001/S013) | William Cook Europe Aps | 2024-07-09 |
| Zenith Dissection Endovascular System (P180001/S012) | William Cook Europe Aps | 2024-04-29 |
| Zenith® Dissection Endovascular System (P180001/S010) | William Cook Europe Aps | 2023-12-15 |