510(k) K090679
K090679 is an FDA 510(k) premarket notification submitted by Vioptix, Inc. for the device "VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 17, 2009. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Vioptix, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2009
- Date Received
- March 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anastomotic, Microvascular
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type