The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Over The Wire Embolectomy Catheter, Model 2302.
| Device ID | K022145 |
| 510k Number | K022145 |
| Device Name: | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 |
| Classification | Catheter, Embolectomy |
| Applicant | LEMAITRE VASCULAR, INC. 26 RAY AVE. Burlington, MA 01803 |
| Contact | James Ashby |
| Correspondent | James Ashby LEMAITRE VASCULAR, INC. 26 RAY AVE. Burlington, MA 01803 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2003-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663100866 | K022145 | 000 |
| 00840663100743 | K022145 | 000 |
| 00840663100736 | K022145 | 000 |
| 00840663100729 | K022145 | 000 |
| 00840663100712 | K022145 | 000 |
| 00840663100705 | K022145 | 000 |
| 00840663100699 | K022145 | 000 |
| 00840663100682 | K022145 | 000 |
| 00840663100675 | K022145 | 000 |
| 00840663100668 | K022145 | 000 |
| 00840663100750 | K022145 | 000 |
| 00840663100767 | K022145 | 000 |
| 00840663100859 | K022145 | 000 |
| 00840663100842 | K022145 | 000 |
| 00840663100835 | K022145 | 000 |
| 00840663100828 | K022145 | 000 |
| 00840663100811 | K022145 | 000 |
| 00840663100804 | K022145 | 000 |
| 00840663100798 | K022145 | 000 |
| 00840663100781 | K022145 | 000 |
| 00840663100774 | K022145 | 000 |
| 00840663100651 | K022145 | 000 |