OrbusNeich Medical (Shenzhen) Co., Ltd.
SHENZHEN Guangdong, CN
OrbusNeich Medical (Shenzhen) Co., Ltd. appears in FDA device records in SHENZHEN Guangdong, CN. FDA records list 9 510(k) clearances between and , 10 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for OrbusNeich Medical (Shenzhen) Co., Ltd. between 2020 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2021 | 1 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253361 | Teleport Glide Microcatheter | DQY | Substantially Equivalent | |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | DQY | Substantially Equivalent | |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | LOX | Substantially Equivalent | |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | LOX | Substantially Equivalent | |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K231608 | Teleport XT Microcatheter | DQY | Substantially Equivalent | |
| K211807 | Sapphire NC 24 | LOX | Substantially Equivalent | |
| K202231 | JADE | LIT | Substantially Equivalent | |
| K201794 | Jade | LIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003775186 | 3003775186 | OrbusNeich Medical (Shenzhen) Co., Ltd. | No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China;, SHENZHEN Guangdong 518038 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain