BARD URETERAL STENT— 510(k) K823487
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K823487 for BARD URETERAL STENT, Substantially Equivalent on 1983-05-27. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FAD
- Device class
- Class 2
- Regulation
- 21 CFR 876.4620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
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 K823487
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 K823487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.