FDA product code DTK: Filter, Intravascular, Cardiovascular
DTK is the FDA product code for filter, intravascular, cardiovascular. It is a Class II device, regulated under 21 CFR 870.3375 and reviewed by the Cardiovascular panel. FDA has cleared 83 510(k) submissions under DTK, 5 in the last five years, from 29 different applicants. The average 510(k) review took 145 days (median 87); 56 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 22 recalls for DTK devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Filter, Intravascular, Cardiovascular |
| Device class | Class II |
| Regulation | 21 CFR 870.3375 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for DTK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 122 |
| 2018 | 2 | 85 |
| 2021 | 2 | 41 |
| 2024 | 5 | 56 |
Compare with all 510(k) review times · Search every DTK clearance
Top DTK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 13 | 2016-04-29 |
| William Cook Europe Aps | 12 | 2024-01-18 |
| Nitinol Medical Technologies, Inc. | 7 | 1997-04-16 |
| Boston Scientific Corp | 6 | 1997-01-06 |
| Cook, Inc. | 4 | 2007-11-08 |
24 more applicants have DTK clearances. See the full list in Caduvo.
Most recent DTK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242612 | Argon Medical Devices, Inc. | Option ELITE Vena Cava Filter System (352506070E 352506100E) | 2024-09-10 | 7 |
| K240578 | B.Braun Medical, Inc. | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | 2024-07-31 | 152 |
| K241507 | Aln S.A.R.L. | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | 2024-06-26 | 29 |
| K240257 | Bd | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | 2024-02-29 | 29 |
| K233680 | William Cook Europe Aps | 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 | 2024-01-18 | 63 |
Recalls for DTK devices
22 product recalls in 13 recall events; 4 initiated in the last five years and 2 still open. Most recent: 2025-09-12.
| Year | Recalls |
|---|---|
| 2019 | 6 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DTK?
DTK is the FDA product code for filter, intravascular, cardiovascular. It is a Class II device, regulated under 21 CFR 870.3375 and reviewed by the Cardiovascular panel.
What device class is DTK?
Class II, regulation 21 CFR 870.3375. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTK?
Across 83 cleared submissions the average was 145 days from receipt to decision (median 87).
Which companies have the most DTK clearances?
C.R. Bard, Inc. (13); William Cook Europe Aps (12); Nitinol Medical Technologies, Inc. (7); Boston Scientific Corp (6); Cook, Inc. (4).
Have DTK devices been recalled?
Yes: 22 product recalls across 13 recall events; the most recent began 2025-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DTK
- Run a recall and safety report across every DTK manufacturer
- Watch product code DTK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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