510(k) K780062 ยท EZL Catheter, Retention Type, Balloon
CATHETER/HEMOSTATIC/GERIATRIC
| Applicant | Kendall Research Center, Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 14, 1978 |
| Received | Jan 12, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780062
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" Open, Classified |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.