BARDEX LUBRI-SIL I.C. FOLEY CATHETER— 510(k) K984136
Substantially EquivalentBard Medical Div.
FDA 510(k) clearance K984136 for BARDEX LUBRI-SIL I.C. FOLEY CATHETER, Substantially Equivalent on 1999-02-16. Applicant: Bard Medical Div.. Device class: 2.
Clearance details
- Applicant
- Bard Medical Div.
- Product code
- Code MJC
- 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 MJC
view all- K233094 — Wellead® Latex Foley Catheter
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- K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- K000251 — SPECTRUM SILICONE FOLEY CATHETER
- K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
More clearances from Bard Medical Div.
view allAdverse events under product code MJC
product code MJC- Injury
- 398
- Malfunction
- 12,582
- Other
- 2
- Total
- 12,982
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 K984136
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 K984136.
Data sourced from openFDA. This site is unofficial and independent of the FDA.