FLEXI-PORT Power Injectable Implantable Port— 510(k) K260916
Substantially EquivalentPortal Access, Inc.
FDA 510(k) clearance K260916 for FLEXI-PORT Power Injectable Implantable Port, Substantially Equivalent on 2026-06-17. Applicant: Portal Access, Inc.. Device class: 2.
Summary
Portal Access's FLEXI-PORT Power Injectable Implantable Port is filed under LJT, implanted subcutaneous intravascular ports and catheters. The power-injectable description comes from the device name; the record gives no sizes.
Class II, 21 CFR 880.5965. General Hospital is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Portal Access filed from Miami Beach, Florida. The decision came 90 calendar days after FDA received it (March 19 to June 17, 2026).
Clearance details
- Applicant
- Portal Access, Inc.
- Product code
- Product 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
- Miami Beach, FL, US
Recent devices under product code LJT
view all- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
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- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
- K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
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.