Broadway 8 BRW084128-01
Broadway 8 BRW084128-01 is a vascular guide-catheter (FDA Class II; FDA product code QJP, Catheter, Percutaneous, Neurovasculature) made by Stryker Corp., cleared under FDA 510(k) K241768 on 19 Dec 2024 and listed in FDA GUDID since 27 Oct 2026 (UDI-DI 07613327694796), active as of 9 Nov 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 | Number07613327694796 | Date27 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241768 | Date19 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 07613327694796
- FDA 510(k) database K241768
Across registries
- FDA 510(k) K241768 decided 19 Dec 2024 Active
- FDA GUDID UDI-DI 07613327694796 listed 27 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K241768
- Listed FDA GUDID 07613327694796
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Broadway 8
- Generic name
- Vascular guide-catheter, single-use
- Model / Ref / Catalog
- BRW084128-01
- Primary DI / UDI-DI
- 07613327694796
- 510(k) Number
- FDA product code
- QJP
- GMDN term
- Vascular guide-catheter, single-use
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- Size
- Lumen/Inner Diameter — 0.084 InchLength — 128.0 Centimeter
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