PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS— 510(k) K973862
Substantially EquivalentSims Deltec, Inc.
FDA 510(k) clearance K973862 for PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS, Substantially Equivalent on 1997-12-29. Applicant: Sims Deltec, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Deltec, 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 Sims Deltec, Inc.
view all- K010426 — PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
- K000842 — CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
- K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
- K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
- K992697 — PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
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 K973862
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 K973862.
Data sourced from openFDA. This site is unofficial and independent of the FDA.