PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS— 510(k) K093414
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K093414 for PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS, Substantially Equivalent on 2010-03-01. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, 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
- St. Paul, MN, 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 Smiths Medical Asd, Inc.
view all- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K181699 — Level 1 Convective Warmer
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 K093414
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 K093414.
Data sourced from openFDA. This site is unofficial and independent of the FDA.