Medical Device Manufacturer · CN , Shenzhen

OrbusNeich Medical (Shenzhen) Co., Ltd. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2020

Recent clearances: JADE SCORE PTA Scoring Balloon Dilatation Catheter, Teleport Glide Microcatheter, COREPASS Modular Microcatheter (FLEX)

10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - OrbusNeich Medical (Shenzhen) Co., Ltd. Cardiovascular ✕

10 devices
1-10 of 10
Cleared Sep 16, 2026
JADE SCORE PTA Scoring Balloon Dilatation Catheter
K261778 · PNO
Cardiovascular · 110d
Cleared Apr 10, 2026
Teleport Glide Microcatheter
K253361 · DQY
Cardiovascular · 192d
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · DQY
Cardiovascular · 130d
Cleared Aug 16, 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · LOX
Cardiovascular · 290d
Cleared Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · LOX
Cardiovascular · 289d
Cleared Jun 11, 2024
JADE PLUS PTA Balloon Dilatation Catheter
K241025 · LIT
Cardiovascular · 57d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608 · DQY
Cardiovascular · 219d
Cleared Oct 14, 2021
Sapphire NC 24
K211807 · LOX
Cardiovascular · 125d
Cleared Dec 10, 2020
JADE
K202231 · LIT
Cardiovascular · 125d
Cleared Jul 28, 2020
Jade
K201794 · LIT
Cardiovascular · 28d
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