The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Lemaitre 8f Occlusion Catheter.
| Device ID | K132022 |
| 510k Number | K132022 |
| Device Name: | LEMAITRE 8F OCCLUSION CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Andrew Hodgkinson |
| Correspondent | Andrew Hodgkinson 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 | 2013-07-01 |
| Decision Date | 2013-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663101665 | K132022 | 000 |
| 00840663101658 | K132022 | 000 |
| 00840663101641 | K132022 | 000 |
| 00840663101634 | K132022 | 000 |