VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System— 510(k) K240578
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K240578 for VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System, Substantially Equivalent on 2024-07-31. Applicant: B.Braun Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- B.Braun Medical, Inc.
- Product code
- Code DTK
- Device class
- Class 2
- Regulation
- 21 CFR 870.3375
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code DTK
view all- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) +4 more
- 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
More clearances from B.Braun Medical, Inc.
view allAdverse events under product code DTK
product code DTK- Death
- 208
- Injury
- 11,286
- Malfunction
- 3,002
- Total
- 14,496
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.