510(k) K162875
- Device
- Sentry IVC Filter
- Applicant
- NOVATE MEDICAL LTD.
- 510(k) number
- K162875
- Product code
- DTK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-17
- Date received
- 2016-10-14
- Regulation
- 870.3375
- Classification name
- Filter, Intravascular, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GORDON CROWLEY
- Address
- Block 11, Galway Technology Park Parkmore Galway IE
FDA Registration Numbers#
- 1722746
- 1721686
- 3009888344
- 1313046
- 3005580113
- 9612452
- 3013764800
- 3002807314
- 2020394
- 1625425
- 9616099
- 1016427
- 3004111573
- 1643817
- 3002808486
- 1820334
- 3006082230
- 3007156625
- 1018233
- 3007080617
- 3009526575
- 3010383847
Source Documents#
Other 510(k) Records For Product Code DTK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. | 2024-09-10 |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. | 2024-07-31 |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | Aln S.A.R.L. | 2024-06-26 |
| K240257 | Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit | Bd | 2024-02-29 |
| K233680 | 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 | William Cook Europe Aps | 2024-01-18 |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2021-07-28 |
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2021-07-28 |
| K181202 | Sentry IVC Filter | Novate Medical , Ltd. | 2018-06-06 |
| K173236 | Sentry IVC Filter | Novate Medical , Ltd. | 2018-02-22 |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2017-11-20 |
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2017-11-20 |
| K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook | Aln Implants Chirurgicaux | 2017-09-08 |
| K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2017-08-07 |
| K161218 | Gianturco-Roehm Bird’s Nest Vena Cava Filter | Cook Incorporated | 2016-07-22 |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit | C.R. Bard, Inc. | 2016-04-29 |
Legacy Summary#
summary
FDA Review#
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