Vena Cava Umbrella Filter, Model 7321
FDA 510(k) K771046 · Edwards Laboratories
510(k) numberK771046
Submission
- Device name
- Vena Cava Umbrella Filter, Model 7321
- Applicant
- Edwards Laboratories
Mchenry, IL, US - Received
- June 10, 1977
- Decision date
- June 22, 1977
- 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 |
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| K801552 | Mod. 9542 Flow-Thru Inject. Temp. SensorKRB · Traditional | 07/28/1980SE |
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| K792441 | Carpentier-Edwards Flex. AnnuloplastyKRH · Traditional | 03/17/1980PT |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | 12/07/1979SE |
| K790047 | Cardiac Output Computer, Mdel 9520ADXG · Traditional | 02/26/1979SE |
| K790022 | Disposable Holder for BioprosthesisDTJ · Traditional | 01/15/1979SE |
| K781535 | Ac Adapter:Models 9525,9526,9527DXG · Traditional | 09/15/1978SE |
| K771663 | Probe & CatheterKRB · Traditional | 09/20/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | 08/26/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | 07/19/1976SE |
Questions and answers
When was Vena Cava Umbrella Filter, Model 7321 cleared by the FDA?
Vena Cava Umbrella Filter, Model 7321 (K771046) received a 510(k) decision of Substantially Equivalent on June 22, 1977, 12 days after the submission was received.
What is the product code of K771046?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.