510(k) K842144
K842144 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE-TEX VASCULAR GRAFT, FEP-RINGED". The FDA issued a decision of Substantially Equivalent on October 1, 1984. 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
- October 1, 1984
- Date Received
- May 30, 1984
- 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