INT, FirstWire GW323AF
by Shanghai Kindly Medical Instruments Co., Ltd.
INT, FirstWire GW323AF is a Class II device made by Shanghai Kindly Medical Instruments Co., Ltd., cleared under FDA 510(k) K180177 and listed in FDA GUDID since 18 Aug 2023 (UDI-DI 06950900919183), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06950900919183 | Date18 Aug 2023 | StatusListed |
| United States | FDA 510(k) | NumberK180177 | Date— | StatusActive |
Official records
- AccessGUDID record 06950900919183
- FDA 510(k) database K180177
Across registries
- FDA 510(k) K180177 Active
- FDA GUDID UDI-DI 06950900919183 listed 18 Aug 2023 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- INT, FirstWire
- Generic name
- Cardiac/peripheral vascular guidewire, single-use
- Model / reference
- GW323AF
- Primary DI / UDI-DI
- 06950900919183
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Cardiac/peripheral vascular guidewire, single-use
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Cardiac/peripheral vascular guidewire, single-use.
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