The following data is part of a premarket notification filed by Lemaitre Vascular Inc. with the FDA for Phastipp.
| Device ID | K212894 |
| 510k Number | K212894 |
| Device Name: | PhasTIPP |
| Classification | Stripper, Vein, External |
| Applicant | LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 |
| Contact | Anurag Gadgil |
| Correspondent | Anurag Gadgil LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 |
| Product Code | DWQ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-03-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PHASTIPP 88642536 not registered Live/Pending |
LeMaitre Vascular, Inc. 2019-10-04 |