In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath— 510(k) K201165
UnknownColoplast Corp.
FDA 510(k) clearance K201165 for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath, Unknown on 2020-12-17. 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.