Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets— 510(k) K211911
UnknownColoplast Corp.
FDA 510(k) clearance K211911 for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets, Unknown on 2022-03-10. Applicant: Coloplast Corp.. Device class: Unclassified.
Clearance details
- Applicant
- Coloplast Corp.
- Product code
- Code LJE
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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More clearances from Coloplast Corp.
view allAdverse 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.