Ultraxx Nephrostomy Balloon Catheter Set— 510(k) K181713
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K181713 for Ultraxx Nephrostomy Balloon Catheter Set, Substantially Equivalent on 2018-08-17. Applicant: Cook Incorporated.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code LJE
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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.