FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Sapphire NC ULTRA Coronary Dilatation Catheter
K Number: K233499
·
Decision Aug 16, 2024
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
85
Applicant Total
9
Review Days
290
Basic Information
- Device Name
- Sapphire NC ULTRA Coronary Dilatation Catheter
- K Number
- K233499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Date Received
- October 31, 2023
- Decision Date
- August 16, 2024
- Product Code
- LOX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |
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FDA Class 2
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Other Clearances by OrbusNeich Medical (Shenzhen) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253361 | Teleport Glide Microcatheter | Apr 10, 2026 | Substantially Equivalent |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | Jan 7, 2025 | Substantially Equivalent |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | Aug 15, 2024 | Substantially Equivalent |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | Jun 11, 2024 | Substantially Equivalent |
| K231608 | Teleport XT Microcatheter | Jan 7, 2024 | Substantially Equivalent |
| K211807 | Sapphire NC 24 | Oct 14, 2021 | Substantially Equivalent |
| K202231 | JADE | Dec 10, 2020 | Substantially Equivalent |
| K201794 | Jade | Jul 28, 2020 | Substantially Equivalent |