510(k) K970843
K970843 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES". The FDA issued a decision of ST on Jun 5, 1997. 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. Intervascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- Jun 5, 1997
- Date Received
- Mar 7, 1997
- 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