The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Pruitt-inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49.
| Device ID | K043023 |
| 510k Number | K043023 |
| Device Name: | PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Saba Modjarrad |
| Correspondent | Saba Modjarrad 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 | 2004-11-03 |
| Decision Date | 2004-12-03 |
| Summary: | summary |