BARDEX LUBRI-SIL FOLEY CATHETER— 510(k) K984084
Substantially EquivalentBard Medical Div.
FDA 510(k) clearance K984084 for BARDEX LUBRI-SIL FOLEY CATHETER, Substantially Equivalent on 1999-02-01. Applicant: Bard Medical Div.. Device class: 2.
Clearance details
- Applicant
- Bard Medical Div.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Covington, GA, US
Recent devices under product code EZL
view allMore clearances from Bard Medical Div.
view allAdverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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 K984084
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 K984084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.