510(k) K831809
K831809 is an FDA 510(k) premarket notification submitted by Thomas J. Fogarty, M.D. for the device "FOGARTY OCCLUDER PAD". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Thomas J. Fogarty, M.D. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1984
- Date Received
- June 6, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type