VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET— 510(k) K062414
Substantially EquivalentRita Medical Systems, Inc.
FDA 510(k) clearance K062414 for VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET, Substantially Equivalent on 2007-02-01. Applicant: Rita Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Rita Medical 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
- Traditional
- Location
- Manchester, GA, 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 Rita Medical Systems, 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 →
Recalls naming K062414
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 K062414.
Data sourced from openFDA. This site is unofficial and independent of the FDA.