510(k) K061727
K061727 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE PRECLUDE VESSEL GUARD". The FDA issued a decision of Substantially Equivalent on August 7, 2006. The device falls under product code MFX (Vessel Guard Or Cover, To Facilitate Revision Surgeries), a Class II device regulated under 21 CFR 870.3470. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2006
- Date Received
- June 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vessel Guard Or Cover, To Facilitate Revision Surgeries
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type
Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection.