Scoreflex NC Scoring PTCA Catheter
FDA premarket approval P200041/S009 · decided 2025-10-29
Approval details
- PMA number
- P200041
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Scoreflex NC Scoring PTCA Catheter
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Date received
- 2025-09-29
- Decision date
- 2025-10-29
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Shenzhen
- Statement
- optimization of manufacturing parameters, adjustments to routine sterility testing and process automation
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Teleport Glide Microcatheter (K253361) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (K242588) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 |
| Sapphire NC ULTRA Coronary Dilatation Catheter (K233499) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 |
| Sapphire ULTRA Coronary Dilatation Catheter (K233505) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 |
| JADE PLUS PTA Balloon Dilatation Catheter (K241025) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 |
| Teleport XT Microcatheter (K231608) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 |
| Sapphire NC 24 (K211807) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 |
| JADE (K202231) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-12-10 |