PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports— 510(k) K242328
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K242328 for PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports, Substantially Equivalent on 2024-10-31. 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 Ciy,, 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
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
- K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.