Micrus Guide Wire, Watusi 0.014
by Micrus Endovascular Corporation
510(k) K053265
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053265 | Date28 Apr 2006 | StatusActive |
Recalls
-
- Terminated Z-1542-06
During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent