X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER— 510(k) K051316
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K051316 for X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER, Substantially Equivalent on 2005-07-18. Applicant: C.R. Bard, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Covington, GA, US
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Adverse events under product code LJE
product code LJE- Death
- 6
- Total
- 6
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.