The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Pruitt F3-s Polyurethane Carotid Shunt.
| Device ID | K152833 |
| 510k Number | K152833 |
| Device Name: | Pruitt F3-S Polyurethane Carotid Shunt |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LEMAITRE VASCULAR, INC. 63 SECOND AVENUE Burlington, MA 01803 |
| Contact | Anna Kasseris |
| Correspondent | Anna Kasseris 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 | 2015-09-29 |
| Decision Date | 2016-01-21 |
| Summary: | summary |