G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS— 510(k) K082305
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K082305 for G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS, Substantially Equivalent on 2008-10-31. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, 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
- Special
- Location
- Tempe, AZ, US
Recent devices under product code DTK
view all- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
- 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
More clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
Adverse 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.