Polyvinyl Alcohol Embolic Microspheres— 510(k) K250209
Substantially EquivalentCanyon Medical, Inc.
FDA 510(k) clearance K250209 for Polyvinyl Alcohol Embolic Microspheres, Substantially Equivalent on 2025-09-23. Applicant: Canyon Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Canyon Medical, Inc.
- Product code
- Code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code KRD
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view all- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241825 — Microwave Ablation Antennas
- K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
- K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
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.