PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more— 510(k) K232737
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K232737 for PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more, Substantially Equivalent on 2023-12-08. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.
Clearance details
- Device name as filed
- PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port
- Applicant
- Bard Peripheral Vascular, 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
- Tempe, AZ, 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
- K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
More clearances from Bard Peripheral Vascular, Inc.
view allAdverse 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.