JADE SCORE PTA Scoring Balloon Dilatation Catheter— 510(k) K261778
Substantially EquivalentOrbusNeich Medical (Shenzhen) Co., Ltd.
FDA 510(k) clearance K261778 for JADE SCORE PTA Scoring Balloon Dilatation Catheter, Substantially Equivalent on 2026-09-16. Applicant: OrbusNeich Medical (Shenzhen) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Product code
- Code PNO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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More clearances from OrbusNeich Medical (Shenzhen) Co., Ltd.
view allAdverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
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.