510(k) K933590
K933590 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT". The FDA issued a decision of Substantially Equivalent on Jan 26, 1994. 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. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 1994
- Date Received
- Jul 26, 1993
- 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
- 510(k)