The following data is part of a premarket notification filed by Lemaitre Vascular Inc. with the FDA for The Unballoon Non-occlusive Catheter; The Unballoon Non-occlusive Modeling Catheter.
| Device ID | K110891 |
| 510k Number | K110891 |
| Device Name: | THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | LEMAITRE VASCULAR INC. 63 SECOND AVENUE Burlington, MA 01803 |
| Contact | Andrew Hodgkinson |
| Correspondent | Andrew Hodgkinson LEMAITRE VASCULAR INC. 63 SECOND AVENUE Burlington, MA 01803 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2011-09-13 |
| Summary: | summary |