BARDPORT TITANIUM PORTS— 510(k) K050310
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K050310 for BARDPORT TITANIUM PORTS, Substantially Equivalent on 2005-04-18. Applicant: Bard Access Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, Inc.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code LJT
view all- K260916 — FLEXI-PORT Power Injectable Implantable Port
- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
- K251253 — PowerPort isp Implantable Port +3 more
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
More clearances from Bard Access Systems, Inc.
view all- K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- K240146 — BD Prevue II Peripheral Vascular Access System
- K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
- K210264 — BD PowerPiCC Catheter
- K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
Adverse events under product code LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
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 →
Recalls naming K050310
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050310.
Data sourced from openFDA. This site is unofficial and independent of the FDA.