The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Pruitt Carotid Kit.
| Device ID | K103356 |
| 510k Number | K103356 |
| Device Name: | PRUITT CAROTID KIT |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Vic Zhang |
| Correspondent | Vic Zhang LEMAITRE VASCULAR, INC. 63 2ND 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 | 2010-11-16 |
| Decision Date | 2010-12-08 |
| Summary: | summary |