Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath— 510(k) K172929
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K172929 for Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath, Substantially Equivalent on 2018-01-10. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code LJE
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, 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.