WEB Detachment Controller WDC-1
WEB Detachment Controller WDC-1 (FGA00175) is a Class III device made by Sequent Medical, Inc., approved under FDA PMA P170032 on 31 Dec 2018 and listed in FDA GUDID since 1 Apr 2019 (UDI-DI 00856956005282), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856956005282 | Date1 Apr 2019 | StatusListed |
| United States | FDA PMAAPPR | NumberP170032 | Date31 Dec 2018 | StatusActive |
Official records
- AccessGUDID record 00856956005282
- FDA PMA database P170032
Across registries
- FDA PMA P170032 decided 31 Dec 2018 Active
- FDA GUDID UDI-DI 00856956005282 listed 1 Apr 2019 Listed
Recalls
-
- Ongoing Z-0170-2023
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
Timeline
- Approved FDA PMA P170032
- Listed FDA GUDID 00856956005282
- Recall initiated FDA recalls Z-0170-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- WEB Detachment Controller
- Generic name
- Vascular implant detacher, electronic, single-use
- Model / Ref / Catalog
- WDC-1, FGA00175
- Primary DI / UDI-DI
- 00856956005282
- PMA number
- FDA product code
- OPR
- GMDN term
- Vascular implant detacher, electronic, single-use
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution