510(k) K830233 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NON-STERILE,SINGLE/SOUBLE LUMEN-CATH
| Applicant | Evermed, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 28, 1983 |
| Received | Jan 25, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Bard Peripheral Vascular Inc Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 Open, Classified |
LJS | None listed |
| Mar 6, 2013 | Bard Access Systems Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600).
Product Usage: H Terminated |
DYB | None listed |
| Mar 6, 2013 | Bard Access Systems Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630).
Product Usage: Hickman and Leonard Catheters are des Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.