Titanium Percutaneous Greenfield Vena Cave Filter
FDA 510(k) K870729 · Medi-Tech, Inc.
510(k) numberK870729
Submission
- Device name
- Titanium Percutaneous Greenfield Vena Cave Filter
- Applicant
- Medi-Tech, Inc.
Watertown, MA, US - Received
- February 25, 1987
- Decision date
- April 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTK – Filter, Intravascular, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3375
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DTK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E)DTK · Special | Argon Medical Devices, Inc. | 09/10/2024SE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | B.Braun Medical, Inc. | 07/31/2024SE |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)DTK · Special | Aln S.A.R.L. | 06/26/2024SE |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery KitDTK · Special | Bd | 02/29/2024SE |
| K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…DTK · Traditional | William Cook Europe Aps | 01/18/2024SE |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Special | William Cook Europe Aps | 07/28/2021SE |
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Special | William Cook Europe Aps | 07/28/2021SE |
| K181202 | Sentry IVC FilterDTK · Special | Novate Medical , Ltd. | 06/06/2018SE |
| K173236 | Sentry IVC FilterDTK · Traditional | Novate Medical , Ltd. | 02/22/2018SE |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Traditional | William Cook Europe Aps | 11/20/2017SE |
More from William Cook Europe Aps
| 510(k) | Device | Decision |
|---|---|---|
| K954457 | Medi-Tech Eddy Intravascular Infusion CatheterKRA · Traditional | 05/15/1996SE |
| K952345 | Medi-Tech Platform Guide CatheterDQY · Traditional | 08/17/1995SE |
| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | 06/01/1995SE |
| K945289 | Doa - Immunoassay Cut-Off CalibratorDKB · Traditional | 12/13/1994SE |
| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | 10/06/1994SE |
| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
Questions and answers
When was Titanium Percutaneous Greenfield Vena Cave Filter cleared by the FDA?
Titanium Percutaneous Greenfield Vena Cave Filter (K870729) received a 510(k) decision of Substantially Equivalent on April 9, 1987, 43 days after the submission was received.
What is the product code of K870729?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.