JADE
FDA 510(k) clearance K202231 · decided 2020-12-10
Clearance details
- K-number
- K202231
- Device name
- JADE
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-07
- Decision date
- 2020-12-10
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Scoreflex NC Scoring PTCA Catheter (P200041/S009) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-10-29 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S008) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-05-30 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S007) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-05-29 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S006) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-29 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S004) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-26 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S003) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-25 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S002) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-01 |
| Scoreflex NC (P200041/S001) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2023-06-29 |