The following data is part of a premarket notification filed by Lemaitre Vascular, Inc with the FDA for Pruitt F3-s Carotid Shunt.
| Device ID | K143454 |
| 510k Number | K143454 |
| Device Name: | Pruitt F3-S Carotid Shunt |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LeMaitre Vascular, Inc 63 Second Avenue Burlington, MA 01803 |
| Contact | Xiang Zhang |
| Correspondent | Xiang Zhang LeMaitre Vascular, Inc 63 Second Avenue Burlington, MA 01803 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-03 |
| Decision Date | 2015-08-27 |
| Summary: | summary |