Chrysalis Intelligence · Sponsors · OrbusNeich Medical (Shenzhen) Co., Ltd.

OrbusNeich Medical (Shenzhen) Co., Ltd.

Shenzhen, CN · 9 510(k) clearances · 10 PMAs

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Total clearances
9
2020-07-28 → 2026-04-10
Last 12 months
1
Product codes
3
Most recent
2026-04-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQY — — — 3 2026-04-10
LOX — — — 3 2024-08-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 3 2024-06-11
Class III

PMA approvals (10)

Total PMA records
10
Originals + supplements
Distinct product codes
1
First decision
2021-12-21
Most recent
2026-07-31
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-31 P200041-S005 Scoreflex NC Scoring PTCA Catheter 135 Review Track For 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-10-29 P200041-S009 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-05-30 P200041-S008 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-05-29 P200041-S007 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-04-29 P200041-S006 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-04-26 P200041-S004 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2025-04-25 P200041-S003 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2024-08-01 P200041-S002 Scoreflex NC Scoring PTCA Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2023-06-29 P200041-S001 Scoreflex NC 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2021-12-21 P200041 Scoreflex NC Scoring PTCA Catheter Original NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-04-10 K253361 Teleport Glide Microcatheter DQY — —
2025-01-07 K242588 COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) DQY — —
2024-08-16 K233499 Sapphire NC ULTRA Coronary Dilatation Catheter LOX — —
2024-08-15 K233505 Sapphire ULTRA Coronary Dilatation Catheter LOX — —
2024-06-11 K241025 JADE PLUS PTA Balloon Dilatation Catheter LIT Class II Cardiovascular
2024-01-07 K231608 Teleport XT Microcatheter DQY — —
2021-10-14 K211807 Sapphire NC 24 LOX — —
2020-12-10 K202231 JADE LIT Class II Cardiovascular
2020-07-28 K201794 Jade LIT Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence