Sapphire NC 24 Coronary Dilatation Catheter 494001512
by OrbusNeich Medical (ShenZhen) Co., Ltd.
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06934955905827 | Date17 Feb 2022 | StatusListed |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Sapphire NC 24 Coronary Dilatation Catheter
- Generic Name
- Coronary angioplasty balloon catheter, basic
- Model / Reference
- 494001512
- Primary DI / UDI-DI
- 06934955905827
- 510(k) Number
- FDA Product Code
- LOX
- GMDN Term
- Coronary angioplasty balloon catheter, basic
- Device Class
- Class II
- Regulation Number
- 870.5100
- GUDID distribution status
- In Commercial Distribution
Other devices from OrbusNeich Medical (ShenZhen) Co., Ltd.
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Properties
Other properties (9)
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No