The following data is part of a premarket notification filed by Lemaitre Vascular with the FDA for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr.
| Device ID | K182916 |
| 510k Number | K182916 |
| Device Name: | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LeMaitre Vascular 63 Second Avenue Burlington, MA 01803 |
| Contact | John N. Bradsher |
| Correspondent | John N. Bradsher LeMaitre Vascular 63 Second Avenue Burlington, MA 01803 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-18 |
| Decision Date | 2018-11-16 |
| Summary: | summary |