Syngo Aortic Valveguide Software
by Siemens Medical Solutions USA, Inc.
510(k) K113027
Syngo Aortic Valveguide Software is a medical device (FDA Class II; FDA product code OWB, Interventional Fluoroscopic X-Ray System) made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K113027 on 22 Nov 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113027 | Date22 Nov 2011 | StatusActive |
Official records
- FDA 510(k) database K113027
Recalls
-
- Terminated Z-0045-2017
The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury
Timeline
- Cleared FDA 510(k) K113027
- Recall initiated FDA recalls Z-0045-2017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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