HEYER-SCHUTE UNIVERSAL URETERAL STENT— 510(k) K823418
Substantially EquivalentAmerican Hospital Supply Corp.
FDA 510(k) clearance K823418 for HEYER-SCHUTE UNIVERSAL URETERAL STENT, Substantially Equivalent on 1982-12-03. Applicant: American Hospital Supply Corp..
Clearance details
- Applicant
- American Hospital Supply Corp.
- Product code
- Code LJE
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, 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.