Zebra AC6074-095-20
Zebra AC6074-095-20 is a Class II device made by Q’Apel Medical, Inc., cleared under FDA 510(k) K240746 on 20 Nov 2024 and listed in FDA GUDID since 3 Jan 2025 (UDI-DI 00857545008189), active as of 23 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 | Number00857545008189 | Date3 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240746 | Date20 Nov 2024 | StatusActive |
Official records
- AccessGUDID record 00857545008189
- FDA 510(k) database K240746
Across registries
- FDA 510(k) K240746 decided 20 Nov 2024 Active
- FDA GUDID UDI-DI 00857545008189 listed 3 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K240746
- Listed FDA GUDID 00857545008189
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zebra
- Generic name
- Vascular guide-catheter, single-use
- Model / Ref / Catalog
- AC6074-095-20
- Primary DI / UDI-DI
- 00857545008189
- 510(k) Number
- FDA product code
- DQY
- GMDN term
- Vascular guide-catheter, single-use
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
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