510(k) K821826
K821826 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "FEP-RINGED GORE-TEX@ VASCULAR GRAFT". The FDA issued a decision of Substantially Equivalent on December 29, 1982. The device falls under product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter), a Class II device regulated under 21 CFR 870.3450. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1982
- Date Received
- June 22, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type