Quattrode™ 3046
Quattrode™ 3046 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K960728 on 22 May 1996 and listed in FDA GUDID since 15 Oct 2015 (UDI-DI 05414734406321), 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 | Number05414734406321 | Date15 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK960728 | Date22 May 1996 | StatusActive |
Official records
- AccessGUDID record 05414734406321
- FDA 510(k) database K960728
Across registries
- FDA 510(k) K960728 decided 22 May 1996 Active
- FDA GUDID UDI-DI 05414734406321 listed 15 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K960728
- Listed FDA GUDID 05414734406321
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Quattrode™
- Generic name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
- Model / Ref / Catalog
- 3046
- Primary DI / UDI-DI
- 05414734406321
- 510(k) Number
- FDA product code
- GZB
- GMDN term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
- Device class
- Class II
- Regulation number
- 882.5880
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 60 Centimeter