The following data is part of a premarket notification filed by Thomas J. Fogarty, M.d. with the FDA for Transluminal Endarterectomy Device.
| Device ID | K884154 |
| 510k Number | K884154 |
| Device Name: | TRANSLUMINAL ENDARTERECTOMY DEVICE |
| Classification | Dialyzer Reprocessing System |
| Applicant | THOMAS J. FOGARTY, M.D. 770 WELCH RD. SUITE 216 Palo Alto, CA 94304 |
| Contact | Shelly Y Monfort |
| Correspondent | Shelly Y Monfort THOMAS J. FOGARTY, M.D. 770 WELCH RD. SUITE 216 Palo Alto, CA 94304 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-03 |
| Decision Date | 1988-12-27 |