FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
JADE
K Number: K202231
·
Decision Dec 10, 2020
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
9
Review Days
125
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JADE
- K Number
- K202231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
- Date Received
- August 7, 2020
- Decision Date
- December 10, 2020
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIT), ordered by most recent decision date.
WAVE PTA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Armada 14 NC PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | Aug 16, 2024 | 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 |
| K201794 | Jade | Jul 28, 2020 | Substantially Equivalent |