HRSpheres Narrow-Size Embolic Microspheres— 510(k) K210562
Substantially EquivalentSuzhou Hengrui Hongyuan Medical Co., Ltd.
FDA 510(k) clearance K210562 for HRSpheres Narrow-Size Embolic Microspheres, Substantially Equivalent on 2021-10-01. Applicant: Suzhou Hengrui Hongyuan Medical Co., Ltd..
Clearance details
- Applicant
- Suzhou Hengrui Hongyuan Medical Co., Ltd.
- Product code
- Code KRD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Adverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
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.