X-Sizer Catheter System
510(k) K021096
X-Sizer Catheter System is a Class II device made by Ev3 Corporation, cleared under FDA 510(k) K021096 on 8 Sep 2004, active as of 11 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021096 | Date8 Sep 2004 | StatusActive |
Official records
- FDA 510(k) database K021096
Recalls
-
- Terminated Z-1108-06
- Terminated Z-1107-06
Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
Timeline
- Cleared FDA 510(k) K021096
- Recall initiated FDA recalls Z-1108-06
- Recall initiated FDA recalls Z-1107-06
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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