DTK — Filter, Intravascular, Cardiovascular Class II
FDA product code DTK covers "Filter, Intravascular, Cardiovascular", a Class II medical device regulated under 21 CFR 870.3375. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTK
- Device Class
- Class II
- Regulation Number
- 870.3375
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242612 | argon medical devices | Option ELITE Vena Cava Filter System (352506070E 352506100E) | September 10, 2024 |
| K240578 | b.braun medical | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter | July 31, 2024 |
| K241507 | aln s.a.r.l | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK | June 26, 2024 |
| K240257 | bd | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | February 29, 2024 |
| K233680 | william cook europe aps | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- | January 18, 2024 |
| K211875 | william cook europe aps | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect | July 28, 2021 |
| K211874 | william cook europe aps | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena | July 28, 2021 |
| K181202 | novate medical | Sentry IVC Filter | June 6, 2018 |
| K173236 | novate medical | Sentry IVC Filter | February 22, 2018 |
| K172584 | william cook europe aps | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena | November 20, 2017 |
| K172557 | william cook europe aps | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena | November 20, 2017 |
| K163699 | aln implants chirurgicaux | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter | September 8, 2017 |
| K171712 | william cook europe aps | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect | August 7, 2017 |
| K162875 | novate medical | Sentry IVC filter | February 17, 2017 |
| K161218 | cook incorporated | Gianturco-Roehm Birds Nest Vena Cava Filter | July 22, 2016 |
| K160866 | c.r. bard | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subc | April 29, 2016 |
| K152765 | b. braun interventional systems | VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM | February 26, 2016 |
| K143405 | rex medical, l.p | Option (TM) ELITE Vena Cava Filter 100cm System | April 16, 2015 |
| K150262 | volcano corporation | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular | April 3, 2015 |
| K143208 | c.r. bard | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subc | December 9, 2014 |