6248VAL
6248VAL is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K052459 on 11 Jan 2006 and listed in FDA GUDID since 3 Apr 2016 (UDI-DI 00885074439860), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00885074439860 | Date3 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052459 | Date11 Jan 2006 | StatusActive |
Official records
- AccessGUDID record 00885074439860
- FDA 510(k) database K052459
Across registries
- FDA 510(k) K052459 decided 11 Jan 2006 Active
- FDA GUDID UDI-DI 00885074439860 listed 3 Apr 2016 Listed
Recalls
-
- Terminated Z-2471-2008
Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised.
Timeline
- Cleared FDA 510(k) K052459
- Recall initiated FDA recalls Z-2471-2008
- Listed FDA GUDID 00885074439860
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Haemostasis valve
- Model / reference
- 6248VAL
- Primary DI / UDI-DI
- 00885074439860
- 510(k) Number
- FDA product code
- DTL
- GMDN term
- Haemostasis valve
- Device class
- Class II
- Regulation number
- 870.4290
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Haemostasis valve.
- DoublePlay™ 00884450650783 by Merit Medical Systems, Inc.
- MBA™ C MAP453 by Merit Medical Systems, Inc.
- Demax DHDT02B by Beijing Demax Medical Technology Co., Ltd.
- Demax DDT03 by Beijing Demax Medical Technology Co., Ltd.
- Check-Flo G06002 CFM-100 by COOK INCORPORATED
- RHV 23245 by Abbott Vascular
- Copilot 1003331 by Abbott Vascular