The following data is part of a premarket notification filed by Thomas J. Fogarty, M.d. with the FDA for Fogarty Occluder Pad.
| Device ID | K831809 |
| 510k Number | K831809 |
| Device Name: | FOGARTY OCCLUDER PAD |
| Classification | Clamp, Vascular |
| Applicant | THOMAS J. FOGARTY, M.D. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-06 |
| Decision Date | 1984-08-27 |