PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A— 510(k) K974471
Substantially EquivalentSims Deltec, Inc.
FDA 510(k) clearance K974471 for PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A, Substantially Equivalent on 1998-01-22. 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
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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 K974471
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 K974471.
Data sourced from openFDA. This site is unofficial and independent of the FDA.