510(k) K093934
K093934 is an FDA 510(k) premarket notification submitted by W.L. Gore & Associates for the device "GORE HYBRID VASCULAR GRAFT". The FDA issued a decision of Substantially Equivalent on March 17, 2010. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. W.L. Gore & Associates has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2010
- Date Received
- December 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type