The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05.
| Device ID | K033159 |
| 510k Number | K033159 |
| Device Name: | LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Brian K Keogh |
| Correspondent | Brian K Keogh LEMAITRE VASCULAR, INC. 63 2ND 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 | 2003-09-30 |
| Decision Date | 2003-12-19 |